theophylline

Generic: theophylline

Labeler: brandywine pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name theophylline
Generic Name theophylline
Labeler brandywine pharmaceuticals, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

theophylline anhydrous 300 mg/1

Manufacturer
Brandywine Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 71321-502
Product ID 71321-502_9c1ede62-fd47-41f4-96da-93d65133042d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA087400
Listing Expiration 2026-12-31
Marketing Start 2025-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71321502
Hyphenated Format 71321-502

Supplemental Identifiers

RxCUI
237178 317769 346574
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 ANDA087400 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71321-502-10)
source: ndc

Packages (1)

71321-502-10 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71321-502-10)

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": "9c1ede62-fd47-41f4-96da-93d65133042d", "openfda": {"nui": ["N0000175790", "M0023046"], "unii": ["0I55128JYK"], "rxcui": ["237178", "317769", "346574"], "spl_set_id": ["7b98b47d-0a6e-4621-b047-bdb8bcef4836"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_epc": ["Methylxanthine [EPC]"], "manufacturer_name": ["Brandywine Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71321-502-10)", "package_ndc": "71321-502-10", "marketing_start_date": "20250930"}], "brand_name": "Theophylline", "product_id": "71321-502_9c1ede62-fd47-41f4-96da-93d65133042d", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "71321-502", "generic_name": "Theophylline", "labeler_name": "Brandywine Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Theophylline", "active_ingredients": [{"name": "THEOPHYLLINE ANHYDROUS", "strength": "300 mg/1"}], "application_number": "ANDA087400", "marketing_category": "ANDA", "marketing_start_date": "20250930", "listing_expiration_date": "20261231"}