celecoxib

Product NDC
33342-156
11-digit product format
333420156
Labeler code
33342
Product ID
33342-156_bab34b9b-3e23-475d-a538-c0e3fe08be49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA204590
Marketing category
ANDA
Marketing start
2016-03-16
Substance
CELECOXIB
Active strength
100 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
celecoxib
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205322, 205323, 349514, 686379

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
cc117a7e-1ef6-4866-90a7-ce0d190eef9aProduct name120200925
827beb42-45f2-95b8-6aa3-f35174375422Product name920160429

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-156-11celecoxib100 in 1 BOTTLECAPSULE10010
33342-156-12celecoxib10 in 1 CARTONCAPSULE1010
33342-156-12celecoxib10 in 1 BLISTER PACKCAPSULE1010
33342-156-15celecoxib500 in 1 BOTTLECAPSULE50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-156-11EA - Each33342-156d3eead34-dc1d-423b-8bfc-9253c9098d4612016-11-08
33342-156-15EA - Each33342-156a8b92a9a-e3c5-4fdc-bd5d-3dcc15772f6612016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-156CELECOXIB CAPSULE [MACLEODS PHARMACEUTICALS LIMITED]8Current NDC, Legacy NDC, 4 package rows20250101_d14aecf5-16e9-459a-bda4-4ca8f290796a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNd14aecf5-16e9-459a-bda4-4ca8f290796a10
205323celecoxib 200 MG Oral CapsulePSNd14aecf5-16e9-459a-bda4-4ca8f290796a10
349514celecoxib 400 MG Oral CapsulePSNd14aecf5-16e9-459a-bda4-4ca8f290796a10
686379celecoxib 50 MG Oral CapsulePSNd14aecf5-16e9-459a-bda4-4ca8f290796a10
205322celecoxib 100 MG Oral CapsuleSCDd14aecf5-16e9-459a-bda4-4ca8f290796a10
205323celecoxib 200 MG Oral CapsuleSCDd14aecf5-16e9-459a-bda4-4ca8f290796a10
349514celecoxib 400 MG Oral CapsuleSCDd14aecf5-16e9-459a-bda4-4ca8f290796a10
686379celecoxib 50 MG Oral CapsuleSCDd14aecf5-16e9-459a-bda4-4ca8f290796a10
205322celecoxib 100 MG Oral CapsulePSN2e1b6011-d3c7-63a0-e054-00144ff88e889
205323celecoxib 200 MG Oral CapsulePSN2e1b6011-d3c7-63a0-e054-00144ff88e889
205322celecoxib 100 MG Oral CapsuleSCD2e1b6011-d3c7-63a0-e054-00144ff88e889
205323celecoxib 200 MG Oral CapsuleSCD2e1b6011-d3c7-63a0-e054-00144ff88e889
205322celecoxib 100 MG Oral CapsulePSN2fc74af6-4573-411d-9082-f3edd44a52a48
205322celecoxib 100 MG Oral CapsuleSCD2fc74af6-4573-411d-9082-f3edd44a52a48
205322celecoxib 100 MG Oral CapsulePSNac5c0d72-1bb3-4065-b2f4-5516b08697757
205322celecoxib 100 MG Oral CapsulePSNac87b4f9-3f66-8cf7-e053-2995a90ade0f7
205322celecoxib 100 MG Oral CapsulePSNc8ade384-2072-2cc2-e053-2a95a90ae7917
205322celecoxib 100 MG Oral CapsulePSNf0df546e-17c9-4e85-839d-336612d7b9e57
205323celecoxib 200 MG Oral CapsulePSNac5c0d72-1bb3-4065-b2f4-5516b08697757
205322celecoxib 100 MG Oral CapsuleSCDac87b4f9-3f66-8cf7-e053-2995a90ade0f7
205322celecoxib 100 MG Oral CapsuleSCDc8ade384-2072-2cc2-e053-2a95a90ae7917
205322celecoxib 100 MG Oral CapsuleSCDac5c0d72-1bb3-4065-b2f4-5516b08697757
205322celecoxib 100 MG Oral CapsuleSCDf0df546e-17c9-4e85-839d-336612d7b9e57
205323celecoxib 200 MG Oral CapsuleSCDac5c0d72-1bb3-4065-b2f4-5516b08697757
205322celecoxib 100 MG Oral CapsulePSNf6291230-7598-407a-aef0-ec1f09277d2a3
205322celecoxib 100 MG Oral CapsuleSCDf6291230-7598-407a-aef0-ec1f09277d2a3
205322celecoxib 100 MG Oral CapsulePSNf8fdd580-09da-9c1c-e053-6394a90a47062
205322celecoxib 100 MG Oral CapsulePSN0ad14a4e-2f05-4ce7-93d1-1cb7e4d8f7d02
205322celecoxib 100 MG Oral CapsuleSCDf8fdd580-09da-9c1c-e053-6394a90a47062
205322celecoxib 100 MG Oral CapsuleSCD0ad14a4e-2f05-4ce7-93d1-1cb7e4d8f7d02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-156-1133342015611100 CAPSULE in 1 BOTTLE (33342-156-11) 100 capsule2016-03-160000-00-00NoNoCurrent
33342-156-123334201561210 BLISTER PACK in 1 CARTON (33342-156-12) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2016-03-160000-00-00NoNoCurrent
33342-156-1533342015615500 CAPSULE in 1 BOTTLE (33342-156-15) 500 capsule2016-03-160000-00-00NoNoCurrent