Label: ANGUSTURA VERA pellet
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NDC Code(s):
63545-005-01,
63545-005-02,
63545-005-03,
63545-005-04, view more63545-006-01, 63545-006-02, 63545-006-03, 63545-006-04, 63545-007-01, 63545-007-02, 63545-007-03, 63545-007-04, 63545-008-01, 63545-008-02, 63545-008-03, 63545-008-04, 63545-009-01, 63545-009-02, 63545-009-03, 63545-009-04, 63545-998-01, 63545-998-02, 63545-998-03, 63545-999-01, 63545-999-02, 63545-999-03
- Packager: Hahnemann Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated December 9, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- DOSAGE FORMS & STRENGTHS
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- PREGNANCY OR BREAST FEEDING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- INSTRUCTIONS FOR USE
- DOSAGE & ADMINISTRATION
- ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ANGUSTURA VERA
angustura vera pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-999 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANGOSTURA BARK (UNII: 104010O5VU) (ANGOSTURA BARK - UNII:104010O5VU) ANGOSTURA BARK 12 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 3mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63545-999-01 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 12/22/2020 2 NDC:63545-999-02 1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 12/22/2020 3 NDC:63545-999-03 4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 12/22/2020 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/22/2020 ANGUSTURA VERA
angustura vera pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-005 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANGOSTURA BARK (UNII: 104010O5VU) (ANGOSTURA BARK - UNII:104010O5VU) ANGOSTURA BARK 200 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 2mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63545-005-02 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 12/22/2020 2 NDC:63545-005-04 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 12/22/2020 3 NDC:63545-005-03 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 12/22/2020 4 NDC:63545-005-01 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 12/22/2020 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/22/2020 ANGUSTURA VERA
angustura vera pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-009 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANGOSTURA BARK (UNII: 104010O5VU) (ANGOSTURA BARK - UNII:104010O5VU) ANGOSTURA BARK 100 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 2mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63545-009-02 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 12/22/2020 2 NDC:63545-009-04 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 12/22/2020 3 NDC:63545-009-03 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 12/22/2020 4 NDC:63545-009-01 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 12/22/2020 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/22/2020 ANGUSTURA VERA
angustura vera pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-008 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANGOSTURA BARK (UNII: 104010O5VU) (ANGOSTURA BARK - UNII:104010O5VU) ANGOSTURA BARK 30 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 3mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63545-008-02 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 12/22/2020 2 NDC:63545-008-04 4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 12/22/2020 3 NDC:63545-008-03 1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 12/22/2020 4 NDC:63545-008-01 80 in 1 VIAL, GLASS; Type 0: Not a Combination Product 12/22/2020 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/22/2020 ANGUSTURA VERA
angustura vera pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-007 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANGOSTURA BARK (UNII: 104010O5VU) (ANGOSTURA BARK - UNII:104010O5VU) ANGOSTURA BARK 1 [hp_M] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 2mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63545-007-02 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 12/22/2020 2 NDC:63545-007-04 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 12/22/2020 3 NDC:63545-007-03 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 12/22/2020 4 NDC:63545-007-01 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 12/22/2020 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/22/2020 ANGUSTURA VERA
angustura vera pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-998 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANGOSTURA BARK (UNII: 104010O5VU) (ANGOSTURA BARK - UNII:104010O5VU) ANGOSTURA BARK 6 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 3mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63545-998-01 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 12/22/2020 2 NDC:63545-998-02 1200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 12/22/2020 3 NDC:63545-998-03 4000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 12/22/2020 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/22/2020 ANGUSTURA VERA
angustura vera pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-006 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANGOSTURA BARK (UNII: 104010O5VU) (ANGOSTURA BARK - UNII:104010O5VU) ANGOSTURA BARK 500 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 2mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63545-006-02 500 in 1 VIAL, GLASS; Type 0: Not a Combination Product 12/22/2020 2 NDC:63545-006-04 10000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 12/22/2020 3 NDC:63545-006-03 3000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 12/22/2020 4 NDC:63545-006-01 200 in 1 VIAL, GLASS; Type 0: Not a Combination Product 12/22/2020 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/22/2020 Labeler - Hahnemann Laboratories, Inc. (147098081) Registrant - Hahnemann Laboratories, Inc. (147098081) Establishment Name Address ID/FEI Business Operations Hahnemann Laboratories, Inc. 147098081 manufacture(63545-998, 63545-999, 63545-007, 63545-008, 63545-009, 63545-005, 63545-006)
