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 SOLUTION
Routes
ORAL
Active Ingredients

theophylline anhydrous 80 mg/15mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-556
Product ID 62135-556_4a2adbbe-acaa-a2bf-e063-6294a90a44c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091156
Listing Expiration 2027-12-31
Marketing Start 2011-04-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135556
Hyphenated Format 62135-556

Supplemental Identifiers

RxCUI
313306
UPC
0362135556471
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 ANDA091156 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/15mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (62135-556-24) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (62135-556-51)
  • 473 mL in 1 BOTTLE (62135-556-47)
source: ndc

Packages (2)

62135-556-24 2 TRAY in 1 BOX (62135-556-24) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (62135-556-51) 62135-556-47 473 mL in 1 BOTTLE (62135-556-47)

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": "4a2adbbe-acaa-a2bf-e063-6294a90a44c3", "openfda": {"nui": ["N0000175790", "M0023046"], "upc": ["0362135556471"], "unii": ["0I55128JYK"], "rxcui": ["313306"], "spl_set_id": ["1b685384-5d96-46fa-b93b-e96538a2cfe7"], "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": "2 TRAY in 1 BOX (62135-556-24)  / 10 CUP in 1 TRAY / 15 mL in 1 CUP (62135-556-51)", "package_ndc": "62135-556-24", "marketing_start_date": "20240531"}, {"sample": false, "description": "473 mL in 1 BOTTLE (62135-556-47)", "package_ndc": "62135-556-47", "marketing_start_date": "20221027"}], "brand_name": "Theophylline", "product_id": "62135-556_4a2adbbe-acaa-a2bf-e063-6294a90a44c3", "dosage_form": "SOLUTION", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "62135-556", "generic_name": "Theophylline", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Theophylline", "active_ingredients": [{"name": "THEOPHYLLINE ANHYDROUS", "strength": "80 mg/15mL"}], "application_number": "ANDA091156", "marketing_category": "ANDA", "marketing_start_date": "20110413", "listing_expiration_date": "20271231"}