Theophylline Extended-release Tablets

SPL v1

SPL

SPL Set ID 7339f98d-b996-4e20-a7a7-315fd2a9fa4d

Route

ORAL

Published

Effective Date 2024-05-22

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Theophylline Anhydrous (300 mg)

Inactive Ingredients

Hypromellose 2208 (100 Mpa.s) Lactose Monohydrate Magnesium Stearate Povidone

Identifiers & Packaging

Pill Appearance

Imprint: 7;29 Shape: capsule Color: white Size: 14 mm Size: 19 mm Score: 2

Marketing Status

ANDA Active Since 2024-05-25

Description

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

Medication Information

Description

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

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

Structured Label Content

Package Label.principal Display Panel (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

Advanced Ingredient Data

[{"name": "THEOPHYLLINE ANHYDROUS", "unii": "0I55128JYK", "classCode": "ACTIB", "strengthNumerator": "300", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "HYPROMELLOSE 2208 (100 MPA.S)", "unii": "B1QE5P712K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "THEOPHYLLINE ANHYDROUS", "unii": "0I55128JYK", "classCode": "ACTIB", "strengthNumerator": "450", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "HYPROMELLOSE 2208 (100 MPA.S)", "unii": "B1QE5P712K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:41:15.653708 · Updated: 2026-03-14T22:05:19.564881