Celecoxib

Product NDC
60505-3847
Requested package NDC
60505-3847-8
11-digit product format
605053847
Labeler code
60505
Product ID
60505-3847_d57a5f95-61f8-12df-9698-47137b229aa6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA204197
Marketing category
ANDA
Marketing start
2015-06-03
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
50 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60505-384760505-3847-8DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204197-001CELECOXIBCELECOXIB50MGCAPSULE / ORALAB2015-06-02
A204197-002CELECOXIBCELECOXIB100MGCAPSULE / ORALAB2015-06-02
A204197-003CELECOXIBCELECOXIB200MGCAPSULE / ORALAB2015-06-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A204197-001AB
A204197-002AB
A204197-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204197-001CELECOXIB50MGCAPSULE / ORALAB2015-06-02caaa826d4ba7…
2026-08-18 06:07:402026-07A204197-002CELECOXIB100MGCAPSULE / ORALAB2015-06-02caaa826d4ba7…
2026-08-18 06:07:402026-07A204197-003CELECOXIB200MGCAPSULE / ORALAB2015-06-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204197-001CELECOXIB50MGCAPSULE / ORALAB2015-06-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204197-002CELECOXIB100MGCAPSULE / ORALAB2015-06-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204197-003CELECOXIB200MGCAPSULE / ORALAB2015-06-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204197-001CELECOXIB50MGCAPSULE / ORALAB2015-06-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204197-002CELECOXIB100MGCAPSULE / ORALAB2015-06-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204197-003CELECOXIB200MGCAPSULE / ORALAB2015-06-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A204197-001CELECOXIB50MGCAPSULE / ORALAB2015-06-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204197-002CELECOXIB100MGCAPSULE / ORALAB2015-06-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204197-003CELECOXIB200MGCAPSULE / ORALAB2015-06-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204197-001CELECOXIB50MGCAPSULE / ORALAB2015-06-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204197-002CELECOXIB100MGCAPSULE / ORALAB2015-06-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204197-003CELECOXIB200MGCAPSULE / ORALAB2015-06-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204197-001CELECOXIB50MGCAPSULE / ORALAB2015-06-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204197-002CELECOXIB100MGCAPSULE / ORALAB2015-06-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204197-003CELECOXIB200MGCAPSULE / ORALAB2015-06-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204197-001CELECOXIB50MGCAPSULE / ORALAB2015-06-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204197-002CELECOXIB100MGCAPSULE / ORALAB2015-06-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204197-003CELECOXIB200MGCAPSULE / ORALAB2015-06-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204197-001CELECOXIB50MGCAPSULE / ORALAB2015-06-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204197-002CELECOXIB100MGCAPSULE / ORALAB2015-06-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204197-003CELECOXIB200MGCAPSULE / ORALAB2015-06-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204197-001CELECOXIB50MGCAPSULE / ORALAB2015-06-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204197-002CELECOXIB100MGCAPSULE / ORALAB2015-06-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204197-003CELECOXIB200MGCAPSULE / ORALAB2015-06-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204197-001CELECOXIB50MGCAPSULE / ORALAB2015-06-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204197-002CELECOXIB100MGCAPSULE / ORALAB2015-06-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204197-003CELECOXIB200MGCAPSULE / ORALAB2015-06-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204197-001CELECOXIB50MGCAPSULE / ORALAB2015-06-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A204197-002CELECOXIB100MGCAPSULE / ORALAB2015-06-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A204197-003CELECOXIB200MGCAPSULE / ORALAB2015-06-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204197-001CELECOXIB50MGCAPSULE / ORALAB2015-06-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204197-002CELECOXIB100MGCAPSULE / ORALAB2015-06-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204197-003CELECOXIB200MGCAPSULE / ORALAB2015-06-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204197-001CELECOXIB50MGCAPSULE / ORALAB2015-06-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204197-002CELECOXIB100MGCAPSULE / ORALAB2015-06-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204197-003CELECOXIB200MGCAPSULE / ORALAB2015-06-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204197-001CELECOXIB50MGCAPSULE / ORALAB2015-06-021e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A204197-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204197-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204197-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204197-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204197-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204197-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204197-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204197-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204197-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204197-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204197-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204197-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204197-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204197-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204197-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204197-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204197-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204197-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204197-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204197-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204197-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204197-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204197-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204197-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204197-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204197-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204197-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204197-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204197-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204197-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204197-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204197-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204197-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204197-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204197-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204197-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204197-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204197-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204197-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204197-001AB11e350fbaab3a…

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
60505-3847-1Celecoxib100 in 1 BOTTLECAPSULE10025
60505-3847-3Celecoxib30 in 1 BOTTLECAPSULE3025
60505-3847-6Celecoxib60 in 1 BOTTLECAPSULE6025
60505-3847-8Celecoxib1000 in 1 BOTTLECAPSULE100025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3847-6EA - Each60505-38471e0337d6-17fb-4733-a4d7-dc71d1e4382012015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CelecoxibACTIVE INGREDIENTJCX84Q7J1LCELECOXIB CAPSULE [APOTEX CORP.]11
CelecoxibACTIVE MOIETYJCX84Q7J1LCELECOXIB CAPSULE [APOTEX CORP.]11
ALCOHOLINACTIVE INGREDIENT3K9958V90MCELECOXIB CAPSULE [APOTEX CORP.]11
AMMONIAINACTIVE INGREDIENT5138Q19F1XCELECOXIB CAPSULE [APOTEX CORP.]11
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3CELECOXIB CAPSULE [APOTEX CORP.]11
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCELECOXIB CAPSULE [APOTEX CORP.]11
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCELECOXIB CAPSULE [APOTEX CORP.]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCELECOXIB CAPSULE [APOTEX CORP.]11
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACELECOXIB CAPSULE [APOTEX CORP.]11
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCELECOXIB CAPSULE [APOTEX CORP.]11
GELATININACTIVE INGREDIENT2G86QN327LCELECOXIB CAPSULE [APOTEX CORP.]11
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302CELECOXIB CAPSULE [APOTEX CORP.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELECOXIB CAPSULE [APOTEX CORP.]11
POVIDONEINACTIVE INGREDIENTFZ989GH94ECELECOXIB CAPSULE [APOTEX CORP.]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CELECOXIB CAPSULE [APOTEX CORP.]11
SHELLACINACTIVE INGREDIENT46N107B71OCELECOXIB CAPSULE [APOTEX CORP.]11
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICELECOXIB CAPSULE [APOTEX CORP.]11
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELECOXIB CAPSULE [APOTEX CORP.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCELECOXIB CAPSULE [APOTEX CORP.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-3847CELECOXIB CAPSULE [APOTEX CORP.]24Legacy NDC, 4 package rows20250302_a62612b3-9564-2b34-be59-6aa5ac53679c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CelecoxibCELECOXIBBryant Ranch Prepackd94849a7-1831-4319-982c-c6b20dc420382026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204197
application number: ANDA204197
CelecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.52572bfb-43f0-4b55-b1fd-231a05c8b83e2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204197
application number: ANDA204197
CelecoxibCELECOXIBApotex Corp.a62612b3-9564-2b34-be59-6aa5ac53679c2026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204197
application number: ANDA204197
ndc (package): 60505-3847-8
ndc (product): 60505-3847
ndc11 (package): 60505384708
CelecoxibCELECOXIBA-S Medication Solutions217265c0-e98e-482c-8af2-f8ac0ab7a0a12024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204197
application number: ANDA204197
CelecoxibCELECOXIBProficient Rx LP6dd743d3-4821-4919-90eb-6d306ca7999f2021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204197
application number: ANDA204197

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNa62612b3-9564-2b34-be59-6aa5ac53679c25
205323celecoxib 200 MG Oral CapsulePSNa62612b3-9564-2b34-be59-6aa5ac53679c25
686379celecoxib 50 MG Oral CapsulePSNa62612b3-9564-2b34-be59-6aa5ac53679c25
205322celecoxib 100 MG Oral CapsuleSCDa62612b3-9564-2b34-be59-6aa5ac53679c25
205323celecoxib 200 MG Oral CapsuleSCDa62612b3-9564-2b34-be59-6aa5ac53679c25
686379celecoxib 50 MG Oral CapsuleSCDa62612b3-9564-2b34-be59-6aa5ac53679c25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-3847-8605053847081000 CAPSULE in 1 BOTTLE (60505-3847-8) 1000 capsule2015-06-030000-00-00NoNoCurrent