theophylline

Generic: theophylline

Labeler: viona pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

theophylline anhydrous 450 mg/1

Manufacturer
Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-174
Product ID 72578-174_1e5a0f45-86aa-498a-9cc3-9f7acc210ed6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218063
Listing Expiration 2026-12-31
Marketing Start 2024-05-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72578174
Hyphenated Format 72578-174

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 ANDA218063 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 450 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-174-01)
source: ndc

Packages (1)

72578-174-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-174-01)

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": "1e5a0f45-86aa-498a-9cc3-9f7acc210ed6", "openfda": {"nui": ["N0000175790", "M0023046"], "unii": ["0I55128JYK"], "rxcui": ["314241", "317769"], "spl_set_id": ["abdfb9b9-9402-4761-9347-8eb1c4d86242"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_epc": ["Methylxanthine [EPC]"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-174-01)", "package_ndc": "72578-174-01", "marketing_start_date": "20240525"}], "brand_name": "Theophylline", "product_id": "72578-174_1e5a0f45-86aa-498a-9cc3-9f7acc210ed6", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "72578-174", "generic_name": "Theophylline", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Theophylline", "active_ingredients": [{"name": "THEOPHYLLINE ANHYDROUS", "strength": "450 mg/1"}], "application_number": "ANDA218063", "marketing_category": "ANDA", "marketing_start_date": "20240525", "listing_expiration_date": "20261231"}