theophylline

Generic: theophylline

Labeler: harman finochem limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

theophylline anhydrous 450 mg/1

Manufacturer
Harman Finochem Limited

Identifiers & Regulatory

Product NDC 82638-106
Product ID 82638-106_171269d1-329b-8551-e063-6294a90aedd7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214806
Listing Expiration 2026-12-31
Marketing Start 2024-05-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82638106
Hyphenated Format 82638-106

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 ANDA214806 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 450 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (82638-106-02)
source: ndc

Packages (1)

82638-106-02 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (82638-106-02)

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": "171269d1-329b-8551-e063-6294a90aedd7", "openfda": {"nui": ["N0000175790", "M0023046"], "unii": ["0I55128JYK"], "rxcui": ["314241", "317769"], "spl_set_id": ["098db8bb-fa9a-4577-b7d9-86caaefc168a"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_epc": ["Methylxanthine [EPC]"], "manufacturer_name": ["Harman Finochem Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (82638-106-02)", "package_ndc": "82638-106-02", "marketing_start_date": "20240730"}], "brand_name": "Theophylline", "product_id": "82638-106_171269d1-329b-8551-e063-6294a90aedd7", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "82638-106", "generic_name": "Theophylline", "labeler_name": "Harman Finochem Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Theophylline", "active_ingredients": [{"name": "THEOPHYLLINE ANHYDROUS", "strength": "450 mg/1"}], "application_number": "ANDA214806", "marketing_category": "ANDA", "marketing_start_date": "20240531", "listing_expiration_date": "20261231"}