theophylline

Generic: theophylline

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

theophylline anhydrous 450 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-442
Product ID 72789-442_4124d48a-f225-330f-e063-6394a90a8376
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215312
Listing Expiration 2026-12-31
Marketing Start 2024-09-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789442
Hyphenated Format 72789-442

Supplemental Identifiers

RxCUI
314241
UPC
0372789442013
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 (source: ndc)
Generic Name theophylline (source: ndc)
Application Number ANDA215312 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 450 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-442-01)
source: ndc

Packages (1)

72789-442-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-442-01)

Ingredients (1)

theophylline anhydrous (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": "4124d48a-f225-330f-e063-6394a90a8376", "openfda": {"nui": ["N0000175790", "M0023046"], "upc": ["0372789442013"], "unii": ["0I55128JYK"], "rxcui": ["314241"], "spl_set_id": ["5e64036a-ee3e-42e7-9e59-881f88a4e298"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_epc": ["Methylxanthine [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-442-01)", "package_ndc": "72789-442-01", "marketing_start_date": "20241016"}], "brand_name": "Theophylline", "product_id": "72789-442_4124d48a-f225-330f-e063-6394a90a8376", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "72789-442", "generic_name": "Theophylline", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Theophylline", "active_ingredients": [{"name": "THEOPHYLLINE ANHYDROUS", "strength": "450 mg/1"}], "application_number": "ANDA215312", "marketing_category": "ANDA", "marketing_start_date": "20240927", "listing_expiration_date": "20261231"}