Label: PHENTERMINE HYDROCHLORIDE tablet, orally disintegrating
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NDC Code(s):
70771-1200-0,
70771-1200-1,
70771-1200-2,
70771-1200-3, view more70771-1200-4, 70771-1200-5, 70771-1200-9, 70771-1201-0, 70771-1201-1, 70771-1201-2, 70771-1201-3, 70771-1201-4, 70771-1201-5, 70771-1201-9, 70771-1202-0, 70771-1202-1, 70771-1202-2, 70771-1202-3, 70771-1202-4, 70771-1202-5, 70771-1202-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: CIV
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 3, 2024
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1200-1 in bottle of 100 Tablets
Phentermine Hydrochloride Orally Disintegrating Tablets, 15 mg
Rx only
100 Tablets
NDC 70771-1201-1 in bottle of 100 Tablets
Phentermine Hydrochloride Orally Disintegrating Tablets, 30 mg
Rx only
100 Tablets
NDC 70771-1202-1 in bottle of 100 Tablets
Phentermine Hydrochloride Orally Disintegrating Tablets, 37.5 mg
Rx only
100 Tablets
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INGREDIENTS AND APPEARANCE
PHENTERMINE HYDROCHLORIDE
phentermine hydrochloride tablet, orally disintegratingProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1200 Route of Administration ORAL DEA Schedule CIV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENTERMINE HYDROCHLORIDE (UNII: 0K2I505OTV) (PHENTERMINE - UNII:C045TQL4WP) PHENTERMINE 15 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) PEPPERMINT (UNII: V95R5KMY2B) POVIDONE K30 (UNII: U725QWY32X) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (round) Size 8mm Flavor PEPPERMINT (peppermint flavour) Imprint Code 703 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1200-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2018 2 NDC:70771-1200-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2018 3 NDC:70771-1200-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2018 4 NDC:70771-1200-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2018 5 NDC:70771-1200-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2018 6 NDC:70771-1200-4 10 in 1 CARTON 02/08/2018 6 NDC:70771-1200-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204663 02/08/2018 PHENTERMINE HYDROCHLORIDE
phentermine hydrochloride tablet, orally disintegratingProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1201 Route of Administration ORAL DEA Schedule CIV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENTERMINE HYDROCHLORIDE (UNII: 0K2I505OTV) (PHENTERMINE - UNII:C045TQL4WP) PHENTERMINE 30 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) PEPPERMINT (UNII: V95R5KMY2B) POVIDONE K30 (UNII: U725QWY32X) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE (white to off-white) Score no score Shape OVAL (oval) Size 14mm Flavor PEPPERMINT (peppermint flavour) Imprint Code 704 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1201-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2018 2 NDC:70771-1201-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2018 3 NDC:70771-1201-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2018 4 NDC:70771-1201-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2018 5 NDC:70771-1201-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2018 6 NDC:70771-1201-4 10 in 1 CARTON 02/08/2018 6 NDC:70771-1201-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204663 02/08/2018 PHENTERMINE HYDROCHLORIDE
phentermine hydrochloride tablet, orally disintegratingProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1202 Route of Administration ORAL DEA Schedule CIV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENTERMINE HYDROCHLORIDE (UNII: 0K2I505OTV) (PHENTERMINE - UNII:C045TQL4WP) PHENTERMINE 37.5 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) PEPPERMINT (UNII: V95R5KMY2B) POVIDONE K30 (UNII: U725QWY32X) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 11mm Flavor PEPPERMINT (PEPPERMINT) Imprint Code 670 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1202-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2018 2 NDC:70771-1202-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2018 3 NDC:70771-1202-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2018 4 NDC:70771-1202-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2018 5 NDC:70771-1202-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2018 6 NDC:70771-1202-4 10 in 1 CARTON 02/08/2018 6 NDC:70771-1202-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204663 02/08/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1200, 70771-1201, 70771-1202) , MANUFACTURE(70771-1200, 70771-1201, 70771-1202)