theophylline

Generic: theophylline

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name theophylline
Generic Name theophylline
Labeler chartwell rx, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

theophylline anhydrous 300 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-457
Product ID 62135-457_459f1504-8f55-630b-e063-6294a90a88d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089763
Listing Expiration 2026-12-31
Marketing Start 2022-06-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135457
Hyphenated Format 62135-457

Supplemental Identifiers

RxCUI
317769
UPC
0362135457907
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 ANDA089763 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-457-90)
source: ndc

Packages (1)

62135-457-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-457-90)

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": "459f1504-8f55-630b-e063-6294a90a88d6", "openfda": {"nui": ["N0000175790", "M0023046"], "upc": ["0362135457907"], "unii": ["0I55128JYK"], "rxcui": ["317769"], "spl_set_id": ["9591d4db-2b88-4f0f-b61e-64ba67626e3d"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_epc": ["Methylxanthine [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-457-90)", "package_ndc": "62135-457-90", "marketing_start_date": "20230212"}], "brand_name": "Theophylline", "product_id": "62135-457_459f1504-8f55-630b-e063-6294a90a88d6", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "62135-457", "generic_name": "Theophylline", "labeler_name": "Chartwell RX, LLC", "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": "20220627", "listing_expiration_date": "20261231"}