Label: LABETALOL HYDROCHLORIDE tablet, film coated
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NDC Code(s):
70771-1163-1,
70771-1163-3,
70771-1163-5,
70771-1163-9, view more70771-1164-1, 70771-1164-3, 70771-1164-5, 70771-1164-9, 70771-1165-1, 70771-1165-3, 70771-1165-5, 70771-1165-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 18, 2022
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- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LABETALOL HYDROCHLORIDE
labetalol hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1163 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LABETALOL HYDROCHLORIDE (UNII: 1GEV3BAW9J) (LABETALOL - UNII:R5H8897N95) LABETALOL HYDROCHLORIDE 100 mg Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color YELLOW (YELLOW) Score 2 pieces Shape ROUND (BICONVEX) Size 8mm Flavor Imprint Code 7;98 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1163-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/05/2017 2 NDC:70771-1163-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/05/2017 3 NDC:70771-1163-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/05/2017 4 NDC:70771-1163-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/05/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207743 12/05/2017 LABETALOL HYDROCHLORIDE
labetalol hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1164 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LABETALOL HYDROCHLORIDE (UNII: 1GEV3BAW9J) (LABETALOL - UNII:R5H8897N95) LABETALOL HYDROCHLORIDE 200 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (OFF-WHITE) Score 2 pieces Shape ROUND (BICONVEX) Size 11mm Flavor Imprint Code 7;99 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1164-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/05/2017 2 NDC:70771-1164-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/05/2017 3 NDC:70771-1164-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/05/2017 4 NDC:70771-1164-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/05/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207743 12/05/2017 LABETALOL HYDROCHLORIDE
labetalol hydrochloride tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1165 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LABETALOL HYDROCHLORIDE (UNII: 1GEV3BAW9J) (LABETALOL - UNII:R5H8897N95) LABETALOL HYDROCHLORIDE 300 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color GREEN (LIGHT GREEN) Score no score Shape ROUND (BICONVEX) Size 11mm Flavor Imprint Code 800 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1165-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/05/2017 2 NDC:70771-1165-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/05/2017 3 NDC:70771-1165-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/05/2017 4 NDC:70771-1165-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/05/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207743 12/05/2017 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1163, 70771-1164, 70771-1165) , MANUFACTURE(70771-1163, 70771-1164, 70771-1165)
