theophylline

Generic: theophylline

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name theophylline
Generic Name theophylline
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

theophylline anhydrous 300 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-025
Product ID 46708-025_0d340b17-907e-4c38-bbd6-c4740495a55a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090430
Listing Expiration 2026-12-31
Marketing Start 2010-11-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708025
Hyphenated Format 46708-025

Supplemental Identifiers

RxCUI
314241 317769
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 ANDA090430 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-30)
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-31)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-71)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-91)
source: ndc

Packages (4)

46708-025-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-30) 46708-025-31 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-31) 46708-025-71 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-71) 46708-025-91 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-91)

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": "0d340b17-907e-4c38-bbd6-c4740495a55a", "openfda": {"nui": ["N0000175790", "M0023046"], "unii": ["0I55128JYK"], "rxcui": ["314241", "317769"], "spl_set_id": ["31f3c720-1597-4d43-9296-33017b90b15f"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_epc": ["Methylxanthine [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-30)", "package_ndc": "46708-025-30", "marketing_start_date": "20101101"}, {"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-31)", "package_ndc": "46708-025-31", "marketing_start_date": "20101101"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-71)", "package_ndc": "46708-025-71", "marketing_start_date": "20101101"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-025-91)", "package_ndc": "46708-025-91", "marketing_start_date": "20101101"}], "brand_name": "Theophylline", "product_id": "46708-025_0d340b17-907e-4c38-bbd6-c4740495a55a", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "46708-025", "generic_name": "Theophylline", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Theophylline", "active_ingredients": [{"name": "THEOPHYLLINE ANHYDROUS", "strength": "300 mg/1"}], "application_number": "ANDA090430", "marketing_category": "ANDA", "marketing_start_date": "20101101", "listing_expiration_date": "20261231"}