theophylline

Generic: theophylline

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name theophylline
Generic Name theophylline
Labeler bryant ranch prepack
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

theophylline anhydrous 80 mg/15mL

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2909
Product ID 71335-2909_8f5bdf04-0913-42db-8349-7121a814b909
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091586
Listing Expiration 2026-12-31
Marketing Start 2012-08-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713352909
Hyphenated Format 71335-2909

Supplemental Identifiers

RxCUI
313306
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 ANDA091586 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/15mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (71335-2909-1)
source: ndc

Packages (1)

71335-2909-1 473 mL in 1 BOTTLE (71335-2909-1)

Ingredients (1)

theophylline anhydrous (80 mg/15mL)

Linked Drug Pages (1)

Theophylline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8f5bdf04-0913-42db-8349-7121a814b909", "openfda": {"nui": ["N0000175790", "M0023046"], "unii": ["0I55128JYK"], "rxcui": ["313306"], "spl_set_id": ["62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_epc": ["Methylxanthine [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (71335-2909-1)", "package_ndc": "71335-2909-1", "marketing_start_date": "20251022"}], "brand_name": "Theophylline", "product_id": "71335-2909_8f5bdf04-0913-42db-8349-7121a814b909", "dosage_form": "SOLUTION", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "71335-2909", "generic_name": "Theophylline", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Theophylline", "active_ingredients": [{"name": "THEOPHYLLINE ANHYDROUS", "strength": "80 mg/15mL"}], "application_number": "ANDA091586", "marketing_category": "ANDA", "marketing_start_date": "20120802", "listing_expiration_date": "20261231"}