theophylline

Generic: theophylline

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name theophylline
Generic Name theophylline
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

theophylline anhydrous 300 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-721
Product ID 68462-721_588a56f6-ac5a-415e-99ac-fdb836e0202f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212184
Listing Expiration 2027-12-31
Marketing Start 2021-06-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462721
Hyphenated Format 68462-721

Supplemental Identifiers

RxCUI
314241 317769
UPC
0368462721018 0368462722015
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 ANDA212184 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-721-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-721-05)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-721-10)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-721-30)
source: ndc

Packages (4)

68462-721-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-721-01) 68462-721-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-721-05) 68462-721-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-721-10) 68462-721-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-721-30)

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": "588a56f6-ac5a-415e-99ac-fdb836e0202f", "openfda": {"nui": ["N0000175790", "M0023046"], "upc": ["0368462721018", "0368462722015"], "unii": ["0I55128JYK"], "rxcui": ["314241", "317769"], "spl_set_id": ["48330a8e-be08-4d38-b8b1-d30fbd5a35de"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_epc": ["Methylxanthine [EPC]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-721-01)", "package_ndc": "68462-721-01", "marketing_start_date": "20210603"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-721-05)", "package_ndc": "68462-721-05", "marketing_start_date": "20210603"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-721-10)", "package_ndc": "68462-721-10", "marketing_start_date": "20210603"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-721-30)", "package_ndc": "68462-721-30", "marketing_start_date": "20210603"}], "brand_name": "Theophylline", "product_id": "68462-721_588a56f6-ac5a-415e-99ac-fdb836e0202f", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "68462-721", "generic_name": "Theophylline", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Theophylline", "active_ingredients": [{"name": "THEOPHYLLINE ANHYDROUS", "strength": "300 mg/1"}], "application_number": "ANDA212184", "marketing_category": "ANDA", "marketing_start_date": "20210603", "listing_expiration_date": "20271231"}