theophylline

Generic: theophylline

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name theophylline
Generic Name theophylline
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

theophylline anhydrous 300 mg/1

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-741
Product ID 23155-741_c8abc0eb-6bb6-4f7b-a7bf-793cf90c5ead
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089763
Listing Expiration 2026-12-31
Marketing Start 2022-06-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23155741
Hyphenated Format 23155-741

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 ANDA089763 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-741-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-741-05)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-741-10)
source: ndc

Packages (3)

23155-741-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-741-01) 23155-741-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-741-05) 23155-741-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-741-10)

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": "c8abc0eb-6bb6-4f7b-a7bf-793cf90c5ead", "openfda": {"nui": ["N0000175790", "M0023046"], "unii": ["0I55128JYK"], "rxcui": ["314241", "317769"], "spl_set_id": ["701fbf9c-e06b-46f4-863b-981acf3021aa"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_epc": ["Methylxanthine [EPC]"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-741-01)", "package_ndc": "23155-741-01", "marketing_start_date": "20220627"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-741-05)", "package_ndc": "23155-741-05", "marketing_start_date": "20220627"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-741-10)", "package_ndc": "23155-741-10", "marketing_start_date": "20220627"}], "brand_name": "Theophylline", "product_id": "23155-741_c8abc0eb-6bb6-4f7b-a7bf-793cf90c5ead", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "23155-741", "generic_name": "Theophylline", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Theophylline", "active_ingredients": [{"name": "THEOPHYLLINE ANHYDROUS", "strength": "300 mg/1"}], "application_number": "ANDA089763", "marketing_category": "ANDA", "marketing_start_date": "20220627", "listing_expiration_date": "20261231"}