celecoxib

Product NDC
33342-157
11-digit product format
333420157
Labeler code
33342
Product ID
33342-157_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
200 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
CELECOXIB200 mg/1

Harmonized Identifiers#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
33342-157-11celecoxib100 in 1 BOTTLECAPSULE10010
33342-157-12celecoxib10 in 1 BLISTER PACKCAPSULE1010
33342-157-12celecoxib10 in 1 CARTONCAPSULE1010
33342-157-15celecoxib500 in 1 BOTTLECAPSULE50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-157-11EA - Each33342-1571c44b721-a6c3-49cd-91e3-c8aa56359d6012016-11-08
33342-157-15EA - Each33342-15743164cd6-a540-4077-9422-fd70cfbdf5b512016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-157CELECOXIB 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
205323celecoxib 200 MG Oral CapsulePSN78d59905-4a78-4d9f-ac29-58790a5b3a9215
205323celecoxib 200 MG Oral CapsuleSCD78d59905-4a78-4d9f-ac29-58790a5b3a9215
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
205323celecoxib 200 MG Oral CapsulePSNb3545cfb-97c3-b896-e053-2a95a90a15a09
205323celecoxib 200 MG Oral CapsuleSCDb3545cfb-97c3-b896-e053-2a95a90a15a09
205323celecoxib 200 MG Oral CapsulePSN50c29846-3426-0310-e054-00144ff8d46c8
205323celecoxib 200 MG Oral CapsuleSCD50c29846-3426-0310-e054-00144ff8d46c8
205322celecoxib 100 MG Oral CapsulePSNac5c0d72-1bb3-4065-b2f4-5516b08697757
205323celecoxib 200 MG Oral CapsulePSNa6000132-ac6c-4b61-a98a-8cc2dd84b3f07
205323celecoxib 200 MG Oral CapsulePSNac5c0d72-1bb3-4065-b2f4-5516b08697757
205323celecoxib 200 MG Oral CapsulePSNaf73fea0-5cd1-0fa2-e053-2a95a90af8fc7
205322celecoxib 100 MG Oral CapsuleSCDac5c0d72-1bb3-4065-b2f4-5516b08697757
205323celecoxib 200 MG Oral CapsuleSCDa6000132-ac6c-4b61-a98a-8cc2dd84b3f07
205323celecoxib 200 MG Oral CapsuleSCDac5c0d72-1bb3-4065-b2f4-5516b08697757
205323celecoxib 200 MG Oral CapsuleSCDaf73fea0-5cd1-0fa2-e053-2a95a90af8fc7
205323celecoxib 200 MG Oral CapsulePSNcbd2d6de-6f0d-4b69-8e27-a1fe08830ba56
205323celecoxib 200 MG Oral CapsuleSCDcbd2d6de-6f0d-4b69-8e27-a1fe08830ba56
205323celecoxib 200 MG Oral CapsulePSN69aebbab-9906-be86-e053-2991aa0aa8a55
205323celecoxib 200 MG Oral CapsuleSCD69aebbab-9906-be86-e053-2991aa0aa8a55
205323celecoxib 200 MG Oral CapsulePSNc213e224-c2fb-726e-e053-2a95a90a21c54
205323celecoxib 200 MG Oral CapsulePSN8e86bdbd-2b1f-774e-e053-2995a90a9c4b4
205323celecoxib 200 MG Oral CapsuleSCDc213e224-c2fb-726e-e053-2a95a90a21c54
205323celecoxib 200 MG Oral CapsuleSCD8e86bdbd-2b1f-774e-e053-2995a90a9c4b4
205323celecoxib 200 MG Oral CapsulePSN2a926010-08e1-44dd-bc6d-ed15374bd0d33
205323celecoxib 200 MG Oral CapsuleSCD2a926010-08e1-44dd-bc6d-ed15374bd0d33
205323celecoxib 200 MG Oral CapsulePSN8e87600d-bd9d-4861-e053-2995a90a32601
205323celecoxib 200 MG Oral CapsulePSN8c175caf-cd48-071f-e053-2995a90aac481
205323celecoxib 200 MG Oral CapsulePSN351f5f07-bdd4-9893-e063-6394a90a72811
205323celecoxib 200 MG Oral CapsuleSCD8c175caf-cd48-071f-e053-2995a90aac481
205323celecoxib 200 MG Oral CapsuleSCD8e87600d-bd9d-4861-e053-2995a90a32601
205323celecoxib 200 MG Oral CapsuleSCD351f5f07-bdd4-9893-e063-6394a90a72811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-157-1133342015711100 CAPSULE in 1 BOTTLE (33342-157-11) 100 capsule2016-03-160000-00-00NoNoCurrent
33342-157-123334201571210 BLISTER PACK in 1 CARTON (33342-157-12) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2016-03-160000-00-00NoNoCurrent
33342-157-1533342015715500 CAPSULE in 1 BOTTLE (33342-157-15) 500 capsule2016-03-160000-00-00NoNoCurrent