theophylline

Generic: theophylline

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name theophylline
Generic Name theophylline
Labeler zydus lifesciences limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

theophylline anhydrous 300 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1782
Product ID 70771-1782_86fdabb8-c881-4695-8127-59b26998e365
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218063
Listing Expiration 2026-12-31
Marketing Start 2024-05-25

Pharmacologic Class

Established (EPC)
methylxanthine [epc]
Chemical Structure
xanthines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707711782
Hyphenated Format 70771-1782

Supplemental Identifiers

RxCUI
314241 317769
UNII
0I55128JYK
NUI
N0000175790 M0023046

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name theophylline (source: ndc)
Generic Name theophylline (source: ndc)
Application Number ANDA218063 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1782-1)
source: ndc

Packages (1)

70771-1782-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1782-1)

Ingredients (1)

theophylline anhydrous (300 mg/1)

Linked Drug Pages (1)

Theophylline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "86fdabb8-c881-4695-8127-59b26998e365", "openfda": {"nui": ["N0000175790", "M0023046"], "unii": ["0I55128JYK"], "rxcui": ["314241", "317769"], "spl_set_id": ["7339f98d-b996-4e20-a7a7-315fd2a9fa4d"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_epc": ["Methylxanthine [EPC]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1782-1)", "package_ndc": "70771-1782-1", "marketing_start_date": "20240525"}], "brand_name": "Theophylline", "product_id": "70771-1782_86fdabb8-c881-4695-8127-59b26998e365", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "70771-1782", "generic_name": "Theophylline", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Theophylline", "active_ingredients": [{"name": "THEOPHYLLINE ANHYDROUS", "strength": "300 mg/1"}], "application_number": "ANDA218063", "marketing_category": "ANDA", "marketing_start_date": "20240525", "listing_expiration_date": "20261231"}