theophylline

Generic: theophylline

Labeler: sun pharmaceutical industries limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name theophylline
Generic Name theophylline
Labeler sun pharmaceutical industries limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

theophylline anhydrous 300 mg/1

Manufacturer
Sun Pharmaceutical Industries Limited

Identifiers & Regulatory

Product NDC 70095-017
Product ID 70095-017_417c9df3-ed15-40ea-a653-b0442f367a54
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214806
Listing Expiration 2026-12-31
Marketing Start 2024-03-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70095017
Hyphenated Format 70095-017

Supplemental Identifiers

RxCUI
314241 317769
UPC
0370095017017
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 ANDA214806 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70095-017-01)
source: ndc

Packages (1)

70095-017-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70095-017-01)

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": "417c9df3-ed15-40ea-a653-b0442f367a54", "openfda": {"nui": ["N0000175790", "M0023046"], "upc": ["0370095017017"], "unii": ["0I55128JYK"], "rxcui": ["314241", "317769"], "spl_set_id": ["417c9df3-ed15-40ea-a653-b0442f367a54"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_epc": ["Methylxanthine [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70095-017-01)", "package_ndc": "70095-017-01", "marketing_start_date": "20240322"}], "brand_name": "Theophylline", "product_id": "70095-017_417c9df3-ed15-40ea-a653-b0442f367a54", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "70095-017", "generic_name": "Theophylline", "labeler_name": "Sun Pharmaceutical Industries Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Theophylline", "active_ingredients": [{"name": "THEOPHYLLINE ANHYDROUS", "strength": "300 mg/1"}], "application_number": "ANDA214806", "marketing_category": "ANDA", "marketing_start_date": "20240322", "listing_expiration_date": "20261231"}