theophylline

Generic: theophylline

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name theophylline
Generic Name theophylline
Labeler ajanta pharma usa inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

theophylline anhydrous 300 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-272
Product ID 27241-272_fbec14fb-bd76-48e7-b61f-b19cd1a3ea2f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218401
Listing Expiration 2027-12-31
Marketing Start 2025-03-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27241272
Hyphenated Format 27241-272

Supplemental Identifiers

RxCUI
314241 317769
UPC
0327241273018 0327241272011
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 (source: ndc)
Generic Name theophylline (source: ndc)
Application Number ANDA218401 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-272-01)
source: ndc

Packages (1)

27241-272-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-272-01)

Ingredients (1)

theophylline anhydrous (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": "fbec14fb-bd76-48e7-b61f-b19cd1a3ea2f", "openfda": {"nui": ["N0000175790", "M0023046"], "upc": ["0327241273018", "0327241272011"], "unii": ["0I55128JYK"], "rxcui": ["314241", "317769"], "spl_set_id": ["7a422c32-bbdf-4297-84f4-9c438c904b0c"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_epc": ["Methylxanthine [EPC]"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-272-01)", "package_ndc": "27241-272-01", "marketing_start_date": "20250326"}], "brand_name": "Theophylline", "product_id": "27241-272_fbec14fb-bd76-48e7-b61f-b19cd1a3ea2f", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "27241-272", "generic_name": "Theophylline", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Theophylline", "active_ingredients": [{"name": "THEOPHYLLINE ANHYDROUS", "strength": "300 mg/1"}], "application_number": "ANDA218401", "marketing_category": "ANDA", "marketing_start_date": "20250326", "listing_expiration_date": "20271231"}