theophylline

Generic: theophylline

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name theophylline
Generic Name theophylline
Labeler pai holdings, llc dba pai pharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

theophylline 80 mg/15mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-4820
Product ID 0121-4820_895f63e5-665b-4227-8e44-6971ba5ce294
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206344
Listing Expiration 2026-12-31
Marketing Start 2016-12-16

Pharmacologic Class

Classes
methylxanthine [epc] xanthines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01214820
Hyphenated Format 0121-4820

Supplemental Identifiers

RxCUI
313306
UNII
C137DTR5RG

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 ANDA206344 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/15mL
source: ndc
Packaging
  • 4 TRAY in 1 CASE (0121-4820-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-4820-15)
source: ndc

Packages (1)

0121-4820-40 4 TRAY in 1 CASE (0121-4820-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-4820-15)

Ingredients (1)

theophylline (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": "895f63e5-665b-4227-8e44-6971ba5ce294", "openfda": {"unii": ["C137DTR5RG"], "rxcui": ["313306"], "spl_set_id": ["32b9780f-c46f-4e0f-9641-2cab60600e6e"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 TRAY in 1 CASE (0121-4820-40)  / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-4820-15)", "package_ndc": "0121-4820-40", "marketing_start_date": "20161216"}], "brand_name": "THEOPHYLLINE", "product_id": "0121-4820_895f63e5-665b-4227-8e44-6971ba5ce294", "dosage_form": "SOLUTION", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "0121-4820", "generic_name": "THEOPHYLLINE", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "THEOPHYLLINE", "active_ingredients": [{"name": "THEOPHYLLINE", "strength": "80 mg/15mL"}], "application_number": "ANDA206344", "marketing_category": "ANDA", "marketing_start_date": "20161216", "listing_expiration_date": "20261231"}