Label: THEOPHYLLINE tablet, extended release
- NDC Code(s): 70771-1782-1, 70771-1783-1
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 22, 2024
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INGREDIENTS AND APPEARANCE
THEOPHYLLINE
theophylline tablet, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1782 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength THEOPHYLLINE ANHYDROUS (UNII: 0I55128JYK) (THEOPHYLLINE ANHYDROUS - UNII:0I55128JYK) THEOPHYLLINE ANHYDROUS 300 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color WHITE (off white) Score 2 pieces Shape CAPSULE (biconvex) Size 14mm Flavor Imprint Code 7;28 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1782-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/25/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA218063 05/25/2024 THEOPHYLLINE
theophylline tablet, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1783 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength THEOPHYLLINE ANHYDROUS (UNII: 0I55128JYK) (THEOPHYLLINE ANHYDROUS - UNII:0I55128JYK) THEOPHYLLINE ANHYDROUS 450 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color WHITE (off white) Score 2 pieces Shape CAPSULE (biconvex) Size 19mm Flavor Imprint Code 7;29 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1783-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/25/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA218063 05/25/2024 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1782, 70771-1783) , MANUFACTURE(70771-1782, 70771-1783)
