theophylline

Generic: theophylline

Labeler: cranbury pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name theophylline
Generic Name theophylline
Labeler cranbury pharmaceuticals, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

theophylline anhydrous 80 mg/15mL

Manufacturer
Cranbury Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 27808-033
Product ID 27808-033_723b1708-84c4-4a42-99bb-475c77bed2ef
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 27808033
Hyphenated Format 27808-033

Supplemental Identifiers

RxCUI
313306
UPC
0327808033017
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 ANDA091586 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/15mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (27808-033-01)
source: ndc

Packages (1)

27808-033-01 473 mL in 1 BOTTLE (27808-033-01)

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": "723b1708-84c4-4a42-99bb-475c77bed2ef", "openfda": {"nui": ["N0000175790", "M0023046"], "upc": ["0327808033017"], "unii": ["0I55128JYK"], "rxcui": ["313306"], "spl_set_id": ["78a99bfe-6ebe-4ace-80b0-ee019921435e"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_epc": ["Methylxanthine [EPC]"], "manufacturer_name": ["Cranbury Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (27808-033-01)", "package_ndc": "27808-033-01", "marketing_start_date": "20120802"}], "brand_name": "Theophylline", "product_id": "27808-033_723b1708-84c4-4a42-99bb-475c77bed2ef", "dosage_form": "SOLUTION", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "27808-033", "generic_name": "Theophylline", "labeler_name": "Cranbury Pharmaceuticals, LLC", "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"}