theophylline

Generic: theophylline

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name theophylline
Generic Name theophylline
Labeler avkare
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

theophylline anhydrous 300 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-922
Product ID 42291-922_48bf9d36-1151-79d1-e063-6394a90aee09
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089763
Listing Expiration 2027-12-31
Marketing Start 2023-04-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291922
Hyphenated Format 42291-922

Supplemental Identifiers

RxCUI
317769
UPC
0342291922013
UNII
0I55128JYK
NUI
N0000175790 M0023046

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 (42291-922-01)
source: ndc

Packages (1)

42291-922-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-922-01)

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": "48bf9d36-1151-79d1-e063-6394a90aee09", "openfda": {"nui": ["N0000175790", "M0023046"], "upc": ["0342291922013"], "unii": ["0I55128JYK"], "rxcui": ["317769"], "spl_set_id": ["f93e20b1-97aa-088d-e053-6394a90a25d4"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_epc": ["Methylxanthine [EPC]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-922-01)", "package_ndc": "42291-922-01", "marketing_start_date": "20230413"}], "brand_name": "Theophylline", "product_id": "42291-922_48bf9d36-1151-79d1-e063-6394a90aee09", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "42291-922", "generic_name": "Theophylline", "labeler_name": "AvKARE", "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": "20230413", "listing_expiration_date": "20271231"}