theophylline

Generic: theophylline

Labeler: teva pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name theophylline
Generic Name theophylline
Labeler teva pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

theophylline 300 mg/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-3310
Product ID 0480-3310_287dcdda-ce6b-4949-bf12-4316f1f4fe00
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216961
Listing Expiration 2026-12-31
Marketing Start 2023-01-27

Pharmacologic Class

Classes
methylxanthine [epc] xanthines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04803310
Hyphenated Format 0480-3310

Supplemental Identifiers

RxCUI
314241 317769
UNII
C137DTR5RG

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 ANDA216961 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0480-3310-01)
source: ndc

Packages (1)

0480-3310-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0480-3310-01)

Ingredients (1)

theophylline (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": "287dcdda-ce6b-4949-bf12-4316f1f4fe00", "openfda": {"unii": ["C137DTR5RG"], "rxcui": ["314241", "317769"], "spl_set_id": ["25eabefa-518b-4030-9b72-01ac8b3deba9"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0480-3310-01)", "package_ndc": "0480-3310-01", "marketing_start_date": "20230127"}], "brand_name": "Theophylline", "product_id": "0480-3310_287dcdda-ce6b-4949-bf12-4316f1f4fe00", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "0480-3310", "generic_name": "Theophylline", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Theophylline", "active_ingredients": [{"name": "THEOPHYLLINE", "strength": "300 mg/1"}], "application_number": "ANDA216961", "marketing_category": "ANDA", "marketing_start_date": "20230127", "listing_expiration_date": "20261231"}