celecoxib

Generic: celecoxib

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

Drug Facts

Product Profile

Brand Name celecoxib
Generic Name celecoxib
Labeler lupin pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

celecoxib 400 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-398
Product ID 68180-398_c7509f8b-4cac-4294-8e22-0e954c75f793
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202240
Listing Expiration 2026-12-31
Marketing Start 2015-08-07

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180398
Hyphenated Format 68180-398

Supplemental Identifiers

RxCUI
205322 205323 349514 686379
UPC
0368180397014 0368180398011
UNII
JCX84Q7J1L
NUI
N0000000160 M0001335 N0000175722

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 celecoxib (source: ndc)
Generic Name celecoxib (source: ndc)
Application Number ANDA202240 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Celecoxib Capsules, 50 mg are available as size "3" capsules having red opaque cap, imprinted with 'LU' in black ink and white opaque body imprinted with 'N41' in black ink, containing white to off-white powder. They are supplied as follows: NDC Number Size NDC 68180-395-07 bottle of 60 Celecoxib Capsules, 100 mg are available as size "3" capsules having blue opaque cap, imprinted with 'LU' in black ink and white opaque body imprinted with 'N42' in black ink, containing white to off-white powder. They are supplied as follows: NDC Number Size NDC 68180-396-01 bottle of 100 NDC 68180-396-02 bottle of 500 NDC 68180-396-03 bottle of 1000 Celecoxib Capsules, 200 mg are size "1" capsules having gold opaque cap, imprinted with 'LU' in black ink and white opaque body imprinted with 'N43' in black ink, containing white to off-white powder. NDC Number Size NDC 68180-399-01 bottle of 100 NDC 68180-399-02 bottle of 500 Celecoxib Capsules, 400 mg are size "00EL" capsules having green opaque cap, imprinted with 'LU' in black ink and white opaque body imprinted with 'N44' in black ink, containing white to off-white powder. NDC Number Size NDC 68180-398-07 bottle of 60 NDC 68180-398-01 bottle of 100 Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Celecoxib Capsules 50 mg – Bottle of 60s NDC 68180-395-07 Bottles of 60s Celecoxib Capsules 100 mg – Bottle of 100s NDC 68180-396-01 Bottles of 100s Celecoxib Capsules 200 mg – Bottle of 100s NDC 68180-397-01 Bottles of 100s Celecoxib Capsules 200 mg – Bottle of 100s NDC 68180-399-01 Bottles of 100s Celecoxib Capsules 400 mg – Bottle of 100s NDC 68180-398-01 Bottles of 100s image-02 image-03 200 mg image-05 image-06
source: label

Packages (0)

No package records.

Ingredients (1)

celecoxib (400 mg/1)

Linked Drug Pages (1)

celecoxib ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c7509f8b-4cac-4294-8e22-0e954c75f793", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0368180397014", "0368180398011"], "unii": ["JCX84Q7J1L"], "rxcui": ["205322", "205323", "349514", "686379"], "spl_set_id": ["560017b1-daf8-464e-b86f-0a75c78002ec"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "celecoxib", "product_id": "68180-398_c7509f8b-4cac-4294-8e22-0e954c75f793", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68180-398", "generic_name": "celecoxib", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "celecoxib", "active_ingredients": [{"name": "CELECOXIB", "strength": "400 mg/1"}], "application_number": "ANDA202240", "marketing_category": "ANDA", "marketing_start_date": "20150807", "listing_expiration_date": "20261231"}