theophylline (anhydrous)

Generic: theophylline anhydrous

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

Drug Facts

Product Profile

Brand Name theophylline (anhydrous)
Generic Name theophylline anhydrous
Labeler westminster pharmaceuticals, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

theophylline anhydrous 600 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-415
Product ID 69367-415_46766222-63b4-478f-aa8b-a23b20476317
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040560
Listing Expiration 2026-12-31
Marketing Start 2025-11-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69367415
Hyphenated Format 69367-415

Supplemental Identifiers

RxCUI
313291 348472
UPC
0369367414012 0369367415019
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 (anhydrous) (source: ndc)
Generic Name theophylline anhydrous (source: ndc)
Application Number ANDA040560 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-415-01)
source: ndc

Packages (1)

69367-415-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-415-01)

Ingredients (1)

theophylline anhydrous (600 mg/1)

Linked Drug Pages (1)

Theophylline (Anhydrous) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "46766222-63b4-478f-aa8b-a23b20476317", "openfda": {"nui": ["N0000175790", "M0023046"], "upc": ["0369367414012", "0369367415019"], "unii": ["0I55128JYK"], "rxcui": ["313291", "348472"], "spl_set_id": ["04f1d1da-ce61-45b3-acf4-903cc81d16da"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_epc": ["Methylxanthine [EPC]"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-415-01)", "package_ndc": "69367-415-01", "marketing_start_date": "20251125"}], "brand_name": "Theophylline (Anhydrous)", "product_id": "69367-415_46766222-63b4-478f-aa8b-a23b20476317", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "69367-415", "generic_name": "Theophylline Anhydrous", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Theophylline", "brand_name_suffix": "(Anhydrous)", "active_ingredients": [{"name": "THEOPHYLLINE ANHYDROUS", "strength": "600 mg/1"}], "application_number": "ANDA040560", "marketing_category": "ANDA", "marketing_start_date": "20251125", "listing_expiration_date": "20261231"}