theophylline

Generic: theophylline

Labeler: atlantic biologicals corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name theophylline
Generic Name theophylline
Labeler atlantic biologicals corp.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

theophylline anhydrous 80 mg/15mL

Manufacturer
ATLANTIC BIOLOGICALS CORP.

Identifiers & Regulatory

Product NDC 17856-0038
Product ID 17856-0038_4524c143-c24e-c35b-e063-6394a90acc56
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 178560038
Hyphenated Format 17856-0038

Supplemental Identifiers

RxCUI
313306
UNII
0I55128JYK
NUI
N0000175790 M0023046

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
  • 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0038-1) / 15 mL in 1 CUP, UNIT-DOSE
source: ndc

Packages (1)

17856-0038-1 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0038-1) / 15 mL in 1 CUP, UNIT-DOSE

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": "4524c143-c24e-c35b-e063-6394a90acc56", "openfda": {"nui": ["N0000175790", "M0023046"], "unii": ["0I55128JYK"], "rxcui": ["313306"], "spl_set_id": ["47e484c2-f59e-4a71-bb97-c90f128ac345"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_epc": ["Methylxanthine [EPC]"], "manufacturer_name": ["ATLANTIC BIOLOGICALS CORP."]}, "finished": true, "packaging": [{"sample": false, "description": "50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0038-1)  / 15 mL in 1 CUP, UNIT-DOSE", "package_ndc": "17856-0038-1", "marketing_start_date": "20240509"}], "brand_name": "Theophylline", "product_id": "17856-0038_4524c143-c24e-c35b-e063-6394a90acc56", "dosage_form": "SOLUTION", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "17856-0038", "generic_name": "Theophylline", "labeler_name": "ATLANTIC BIOLOGICALS CORP.", "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"}