theophylline

Generic: theophylline

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name theophylline
Generic Name theophylline
Labeler amneal pharmaceuticals ny llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

theophylline anhydrous 450 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 60219-2046
Product ID 60219-2046_8d9dfe98-c0ba-44aa-a349-33c8d0a8bbdf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216276
Listing Expiration 2026-12-31
Marketing Start 2023-03-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 602192046
Hyphenated Format 60219-2046

Supplemental Identifiers

RxCUI
314241 317769
UPC
0360219204614 0360219204515
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 ANDA216276 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 450 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2046-1)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2046-3)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2046-5)
source: ndc

Packages (3)

60219-2046-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2046-1) 60219-2046-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2046-3) 60219-2046-5 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2046-5)

Ingredients (1)

theophylline anhydrous (450 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": "8d9dfe98-c0ba-44aa-a349-33c8d0a8bbdf", "openfda": {"nui": ["N0000175790", "M0023046"], "upc": ["0360219204614", "0360219204515"], "unii": ["0I55128JYK"], "rxcui": ["314241", "317769"], "spl_set_id": ["b0d5d1cd-c79b-4229-929c-2eb3e4f43298"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_epc": ["Methylxanthine [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2046-1)", "package_ndc": "60219-2046-1", "marketing_start_date": "20230327"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2046-3)", "package_ndc": "60219-2046-3", "marketing_start_date": "20230327"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60219-2046-5)", "package_ndc": "60219-2046-5", "marketing_start_date": "20230327"}], "brand_name": "theophylline", "product_id": "60219-2046_8d9dfe98-c0ba-44aa-a349-33c8d0a8bbdf", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "60219-2046", "generic_name": "theophylline", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "theophylline", "active_ingredients": [{"name": "THEOPHYLLINE ANHYDROUS", "strength": "450 mg/1"}], "application_number": "ANDA216276", "marketing_category": "ANDA", "marketing_start_date": "20230327", "listing_expiration_date": "20261231"}