CELEBREX

Product NDC
66336-940
11-digit product format
663360940
Labeler code
66336
Product ID
66336-940_d68cf56e-4789-449f-aab0-49d58b2e2f76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
NDA020998
Marketing category
NDA
Marketing start
1998-10-02
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
100 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66336-940IInactivated by FDA2026-08-07
excluded packagepackage66336-94066336-940-60IInactivated by FDA2026-08-07

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66336-940-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-940-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-940-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-940-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-940-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-940-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66336-940-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66336-940-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66336-940-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66336-940-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66336-940-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66336-940-60557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66336-940-608af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66336-940-60834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66336-940-601332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66336-940-60fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66336-940-6086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66336-940-60bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66336-940-608dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66336-940-60e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage66336-940-609bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage66336-940-60110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020998-001CELEBREXCELECOXIB100MGCAPSULE / ORALABRLD1998-12-31
N020998-002CELEBREXCELECOXIB200MGCAPSULE / ORALABRLD1998-12-31
N020998-003CELEBREXCELECOXIB400MGCAPSULE / ORALABRLD, RS2002-08-29
N020998-004CELEBREXCELECOXIB50MGCAPSULE / ORALABRLD2006-12-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N020998-001AB
N020998-002AB
N020998-003AB
N020998-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020998-001CELEBREX100MGCAPSULE / ORALABRLD1998-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020998-002CELEBREX200MGCAPSULE / ORALABRLD1998-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020998-003CELEBREX400MGCAPSULE / ORALABRLD, RS2002-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020998-004CELEBREX50MGCAPSULE / ORALABRLD2006-12-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020998-001CELEBREX100MGCAPSULE / ORALABRLD1998-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020998-002CELEBREX200MGCAPSULE / ORALABRLD1998-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020998-003CELEBREX400MGCAPSULE / ORALABRLD, RS2002-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020998-004CELEBREX50MGCAPSULE / ORALABRLD2006-12-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N020998-001CELEBREX100MGCAPSULE / ORALABRLD1998-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020998-002CELEBREX200MGCAPSULE / ORALABRLD1998-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020998-003CELEBREX400MGCAPSULE / ORALABRLD, RS2002-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020998-004CELEBREX50MGCAPSULE / ORALABRLD2006-12-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020998-001CELEBREX100MGCAPSULE / ORALABRLD1998-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020998-002CELEBREX200MGCAPSULE / ORALABRLD1998-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020998-003CELEBREX400MGCAPSULE / ORALABRLD, RS2002-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020998-004CELEBREX50MGCAPSULE / ORALABRLD2006-12-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020998-001CELEBREX100MGCAPSULE / ORALABRLD1998-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020998-002CELEBREX200MGCAPSULE / ORALABRLD1998-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020998-003CELEBREX400MGCAPSULE / ORALABRLD, RS2002-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020998-004CELEBREX50MGCAPSULE / ORALABRLD2006-12-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020998-001CELEBREX100MGCAPSULE / ORALABRLD1998-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020998-002CELEBREX200MGCAPSULE / ORALABRLD1998-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020998-003CELEBREX400MGCAPSULE / ORALABRLD, RS2002-08-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020998-004CELEBREX50MGCAPSULE / ORALABRLD2006-12-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020998-001CELEBREX100MGCAPSULE / ORALABRLD1998-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020998-002CELEBREX200MGCAPSULE / ORALABRLD1998-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020998-003CELEBREX400MGCAPSULE / ORALABRLD, RS2002-08-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020998-004CELEBREX50MGCAPSULE / ORALABRLD2006-12-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020998-001CELEBREX100MGCAPSULE / ORALABRLD1998-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020998-002CELEBREX200MGCAPSULE / ORALABRLD1998-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020998-003CELEBREX400MGCAPSULE / ORALABRLD, RS2002-08-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020998-004CELEBREX50MGCAPSULE / ORALABRLD2006-12-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020998-001CELEBREX100MGCAPSULE / ORALABRLD1998-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020998-002CELEBREX200MGCAPSULE / ORALABRLD1998-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020998-003CELEBREX400MGCAPSULE / ORALABRLD, RS2002-08-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020998-004CELEBREX50MGCAPSULE / ORALABRLD2006-12-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020998-001CELEBREX100MGCAPSULE / ORALABRLD1998-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N020998-002CELEBREX200MGCAPSULE / ORALABRLD1998-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N020998-003CELEBREX400MGCAPSULE / ORALABRLD, RS2002-08-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N020998-004CELEBREX50MGCAPSULE / ORALABRLD2006-12-15d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020998-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020998-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020998-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020998-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020998-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020998-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020998-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020998-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020998-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020998-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020998-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020998-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020998-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020998-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020998-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020998-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020998-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020998-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020998-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020998-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020998-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020998-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020998-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020998-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020998-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020998-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020998-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020998-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020998-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020998-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020998-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020998-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020998-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020998-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020998-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020998-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020998-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020998-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020998-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020998-004AB1d06236e962d9…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-940-60CELEBREX60 in 1 BOTTLE, PLASTICCAPSULE602

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-940CELEBREX (CELECOXIB) CAPSULE [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 1 package rows20131107_0dcc7017-31c2-4979-ad33-2dc7f7a53d43.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CELEBREXCELECOXIBViatris Specialty LLC2d6675e4-5859-4be2-8037-a20ce9f707aa2024-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020998
application number: NDA020998

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213468CeleBREX 100 MG Oral CapsulePSN0dcc7017-31c2-4979-ad33-2dc7f7a53d432
205322celecoxib 100 MG Oral CapsulePSN0dcc7017-31c2-4979-ad33-2dc7f7a53d432
213468celecoxib 100 MG Oral Capsule [Celebrex]SBD0dcc7017-31c2-4979-ad33-2dc7f7a53d432
205322celecoxib 100 MG Oral CapsuleSCD0dcc7017-31c2-4979-ad33-2dc7f7a53d432
213468Celebrex 100 MG Oral CapsuleSY0dcc7017-31c2-4979-ad33-2dc7f7a53d432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-940-606633609406060 in 1 BOTTLE, PLASTICHistorical