celecoxib

Generic: celecoxib

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name celecoxib
Generic Name celecoxib
Labeler alembic pharmaceuticals limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

celecoxib 200 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-269
Product ID 46708-269_c884ffd4-3a40-48a1-99b6-73b1ef9324b4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204519
Listing Expiration 2026-12-31
Marketing Start 2015-08-22

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 46708269
Hyphenated Format 46708-269

Supplemental Identifiers

RxCUI
205322 205323 349514 686379
UPC
0346708267308 0346708268305 0346708269302 0346708270308
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 ANDA204519 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 80 CAPSULE in 1 CARTON (46708-269-12)
  • 30 CAPSULE in 1 BOTTLE (46708-269-30)
  • 100 CAPSULE in 1 BOTTLE (46708-269-31)
  • 60 CAPSULE in 1 BOTTLE (46708-269-60)
  • 500 CAPSULE in 1 BOTTLE (46708-269-71)
  • 1000 CAPSULE in 1 BOTTLE (46708-269-91)
source: ndc

Packages (6)

46708-269-12 80 CAPSULE in 1 CARTON (46708-269-12) 46708-269-30 30 CAPSULE in 1 BOTTLE (46708-269-30) 46708-269-31 100 CAPSULE in 1 BOTTLE (46708-269-31) 46708-269-60 60 CAPSULE in 1 BOTTLE (46708-269-60) 46708-269-71 500 CAPSULE in 1 BOTTLE (46708-269-71) 46708-269-91 1000 CAPSULE in 1 BOTTLE (46708-269-91)

Ingredients (1)

celecoxib (200 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": "c884ffd4-3a40-48a1-99b6-73b1ef9324b4", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0346708267308", "0346708268305", "0346708269302", "0346708270308"], "unii": ["JCX84Q7J1L"], "rxcui": ["205322", "205323", "349514", "686379"], "spl_set_id": ["14e8d788-e44c-4a40-8678-25cf45fed477"], "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": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "80 CAPSULE in 1 CARTON (46708-269-12)", "package_ndc": "46708-269-12", "marketing_start_date": "20150822"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (46708-269-30)", "package_ndc": "46708-269-30", "marketing_start_date": "20150822"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (46708-269-31)", "package_ndc": "46708-269-31", "marketing_start_date": "20150822"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (46708-269-60)", "package_ndc": "46708-269-60", "marketing_start_date": "20150822"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (46708-269-71)", "package_ndc": "46708-269-71", "marketing_start_date": "20150822"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (46708-269-91)", "package_ndc": "46708-269-91", "marketing_start_date": "20150822"}], "brand_name": "Celecoxib", "product_id": "46708-269_c884ffd4-3a40-48a1-99b6-73b1ef9324b4", "dosage_form": "CAPSULE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "46708-269", "generic_name": "Celecoxib", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Celecoxib", "active_ingredients": [{"name": "CELECOXIB", "strength": "200 mg/1"}], "application_number": "ANDA204519", "marketing_category": "ANDA", "marketing_start_date": "20150822", "listing_expiration_date": "20261231"}