theophylline

Generic: theophylline

Labeler: chartwell governmental & specialty rx, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name theophylline
Generic Name theophylline
Labeler chartwell governmental & specialty rx, llc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

theophylline anhydrous 80 mg/15mL

Manufacturer
Chartwell Governmental & Specialty RX, LLC.

Identifiers & Regulatory

Product NDC 68999-556
Product ID 68999-556_43905546-0c51-ab49-e063-6294a90a4a31
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091156
Listing Expiration 2026-12-31
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 68999556
Hyphenated Format 68999-556

Supplemental Identifiers

RxCUI
313306
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 (68999-556-24) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (68999-556-51)
source: ndc

Packages (1)

68999-556-24 2 TRAY in 1 BOX (68999-556-24) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (68999-556-51)

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": "43905546-0c51-ab49-e063-6294a90a4a31", "openfda": {"nui": ["N0000175790", "M0023046"], "unii": ["0I55128JYK"], "rxcui": ["313306"], "spl_set_id": ["e2716dac-8b23-4e06-bc3e-4dd76b7c813e"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_epc": ["Methylxanthine [EPC]"], "manufacturer_name": ["Chartwell Governmental & Specialty RX, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (68999-556-24)  / 10 CUP in 1 TRAY / 15 mL in 1 CUP (68999-556-51)", "package_ndc": "68999-556-24", "marketing_start_date": "20251113"}], "brand_name": "Theophylline", "product_id": "68999-556_43905546-0c51-ab49-e063-6294a90a4a31", "dosage_form": "SOLUTION", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "68999-556", "generic_name": "Theophylline", "labeler_name": "Chartwell Governmental & Specialty 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": "20261231"}