theophylline

Generic: theophylline

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

theophylline 450 mg/1

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-227
Product ID 69315-227_a7dacdee-6f6b-4b85-b051-7779258a6971
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214950
Listing Expiration 2026-12-31
Marketing Start 2023-05-15

Pharmacologic Class

Classes
methylxanthine [epc] xanthines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69315227
Hyphenated Format 69315-227

Supplemental Identifiers

RxCUI
314241 317769
UPC
0369315227015 0369315226018
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 ANDA214950 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 450 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-227-01)
source: ndc

Packages (1)

69315-227-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-227-01)

Ingredients (1)

theophylline (450 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": "a7dacdee-6f6b-4b85-b051-7779258a6971", "openfda": {"upc": ["0369315227015", "0369315226018"], "unii": ["C137DTR5RG"], "rxcui": ["314241", "317769"], "spl_set_id": ["ac490ebf-24e1-47c4-a932-ad4dcafe7aad"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-227-01)", "package_ndc": "69315-227-01", "marketing_start_date": "20230515"}], "brand_name": "THEOPHYLLINE", "product_id": "69315-227_a7dacdee-6f6b-4b85-b051-7779258a6971", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "69315-227", "generic_name": "THEOPHYLLINE", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "THEOPHYLLINE", "active_ingredients": [{"name": "THEOPHYLLINE", "strength": "450 mg/1"}], "application_number": "ANDA214950", "marketing_category": "ANDA", "marketing_start_date": "20230515", "listing_expiration_date": "20261231"}