THEOPHYLLINE tablet, extended release

Theophylline by

Drug Labeling and Warnings

Theophylline by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Theophylline extended-release tablets, 300 mg

100 Tablets

NDC: 70771-1782-1

Rx only

Theophylline extended-release tablets, 450 mg

100 Tablets

NDC: 70771-1783-1

Rx only

INGREDIENTS AND APPEARANCE

THEOPHYLLINE 
theophylline tablet, extended release

Product 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 release

Product 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)