theophylline (anhydrous)

Generic: theophylline

Labeler: golden state medical supply, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name theophylline (anhydrous)
Generic Name theophylline
Labeler golden state medical supply, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

theophylline anhydrous 400 mg/1

Manufacturer
Golden State Medical Supply, Inc.

Identifiers & Regulatory

Product NDC 51407-318
Product ID 51407-318_1041830e-393c-1772-e063-6394a90a7d7e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040560
Listing Expiration 2026-12-31
Marketing Start 2006-04-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51407318
Hyphenated Format 51407-318

Supplemental Identifiers

RxCUI
313291 348472
UNII
0I55128JYK
NUI
N0000175790 M0023046

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 (source: ndc)
Application Number ANDA040560 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51407-318-01)
source: ndc

Packages (1)

51407-318-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51407-318-01)

Ingredients (1)

theophylline anhydrous (400 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": "1041830e-393c-1772-e063-6394a90a7d7e", "openfda": {"nui": ["N0000175790", "M0023046"], "unii": ["0I55128JYK"], "rxcui": ["313291", "348472"], "spl_set_id": ["aa80b9f4-8a5d-3e14-e053-2a95a90a8aab"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_epc": ["Methylxanthine [EPC]"], "manufacturer_name": ["Golden State Medical Supply, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51407-318-01)", "package_ndc": "51407-318-01", "marketing_start_date": "20200130"}], "brand_name": "Theophylline (Anhydrous)", "product_id": "51407-318_1041830e-393c-1772-e063-6394a90a7d7e", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "51407-318", "generic_name": "Theophylline", "labeler_name": "Golden State Medical Supply, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Theophylline", "brand_name_suffix": "(Anhydrous)", "active_ingredients": [{"name": "THEOPHYLLINE ANHYDROUS", "strength": "400 mg/1"}], "application_number": "ANDA040560", "marketing_category": "ANDA", "marketing_start_date": "20060421", "listing_expiration_date": "20261231"}