Celecoxib

Product NDC
68788-8679
Requested package NDC
68788-8679-3
11-digit product format
687888679
Labeler code
68788
Product ID
68788-8679_39a398b1-faec-4f99-9ed7-c9444f41cfba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA210071
Marketing category
ANDA
Marketing start
2024-05-29
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A210071-001CELECOXIBCELECOXIB50MGCAPSULE / ORALAB2018-01-23
A210071-002CELECOXIBCELECOXIB100MGCAPSULE / ORALAB2018-01-23
A210071-003CELECOXIBCELECOXIB200MGCAPSULE / ORALAB2018-01-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210071-001AB
A210071-002AB
A210071-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210071-001CELECOXIB50MGCAPSULE / ORALAB2018-01-2384e616aacf4f…
2026-09-14 22:38:342026-08A210071-002CELECOXIB100MGCAPSULE / ORALAB2018-01-2384e616aacf4f…
2026-09-14 22:38:342026-08A210071-003CELECOXIB200MGCAPSULE / ORALAB2018-01-2384e616aacf4f…
2026-08-18 06:07:402026-07A210071-001CELECOXIB50MGCAPSULE / ORALAB2018-01-23caaa826d4ba7…
2026-08-18 06:07:402026-07A210071-002CELECOXIB100MGCAPSULE / ORALAB2018-01-23caaa826d4ba7…
2026-08-18 06:07:402026-07A210071-003CELECOXIB200MGCAPSULE / ORALAB2018-01-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210071-001CELECOXIB50MGCAPSULE / ORALAB2018-01-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210071-002CELECOXIB100MGCAPSULE / ORALAB2018-01-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210071-003CELECOXIB200MGCAPSULE / ORALAB2018-01-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210071-001CELECOXIB50MGCAPSULE / ORALAB2018-01-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210071-002CELECOXIB100MGCAPSULE / ORALAB2018-01-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210071-003CELECOXIB200MGCAPSULE / ORALAB2018-01-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A210071-001CELECOXIB50MGCAPSULE / ORALAB2018-01-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210071-002CELECOXIB100MGCAPSULE / ORALAB2018-01-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210071-003CELECOXIB200MGCAPSULE / ORALAB2018-01-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210071-001CELECOXIB50MGCAPSULE / ORALAB2018-01-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210071-002CELECOXIB100MGCAPSULE / ORALAB2018-01-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210071-003CELECOXIB200MGCAPSULE / ORALAB2018-01-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210071-001CELECOXIB50MGCAPSULE / ORALAB2018-01-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210071-002CELECOXIB100MGCAPSULE / ORALAB2018-01-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210071-003CELECOXIB200MGCAPSULE / ORALAB2018-01-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210071-001CELECOXIB50MGCAPSULE / ORALAB2018-01-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210071-002CELECOXIB100MGCAPSULE / ORALAB2018-01-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210071-003CELECOXIB200MGCAPSULE / ORALAB2018-01-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210071-001CELECOXIB50MGCAPSULE / ORALAB2018-01-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210071-002CELECOXIB100MGCAPSULE / ORALAB2018-01-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210071-003CELECOXIB200MGCAPSULE / ORALAB2018-01-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210071-001CELECOXIB50MGCAPSULE / ORALAB2018-01-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210071-002CELECOXIB100MGCAPSULE / ORALAB2018-01-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210071-003CELECOXIB200MGCAPSULE / ORALAB2018-01-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210071-001CELECOXIB50MGCAPSULE / ORALAB2018-01-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210071-002CELECOXIB100MGCAPSULE / ORALAB2018-01-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210071-003CELECOXIB200MGCAPSULE / ORALAB2018-01-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210071-001CELECOXIB50MGCAPSULE / ORALAB2018-01-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A210071-002CELECOXIB100MGCAPSULE / ORALAB2018-01-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A210071-003CELECOXIB200MGCAPSULE / ORALAB2018-01-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210071-001CELECOXIB50MGCAPSULE / ORALAB2018-01-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210071-002CELECOXIB100MGCAPSULE / ORALAB2018-01-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210071-003CELECOXIB200MGCAPSULE / ORALAB2018-01-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210071-001CELECOXIB50MGCAPSULE / ORALAB2018-01-23301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A210071-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A210071-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A210071-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A210071-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210071-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210071-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210071-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210071-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210071-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210071-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210071-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210071-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210071-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210071-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210071-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210071-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210071-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210071-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210071-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210071-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210071-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210071-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210071-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210071-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210071-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210071-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210071-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210071-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210071-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210071-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210071-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210071-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210071-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210071-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210071-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210071-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210071-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210071-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210071-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210071-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JCX84Q7J1LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
205323Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b0839895-6a36-4e4f-9336-98632b60622aAvailable on FDA.report

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
68788-8679-1Celecoxib100 in 1 BOTTLECAPSULE1003
68788-8679-3Celecoxib30 in 1 BOTTLECAPSULE303
68788-8679-6Celecoxib60 in 1 BOTTLECAPSULE603
68788-8679-8Celecoxib120 in 1 BOTTLECAPSULE1203
68788-8679-9Celecoxib90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8679-1EA - Each68788-86798d10fca3-71e4-4f7c-90cd-0a7c314e0cfe12024-07-12
68788-8679-3EA - Each68788-867990dcb073-99e2-4e9c-a52e-4ea678613e3512024-07-12
68788-8679-6EA - Each68788-8679dce92caf-14d1-4d75-bc06-664a2077632612024-07-12
68788-8679-8EA - Each68788-86792a22cb73-9331-41ed-ad87-612c217c91d112024-07-12
68788-8679-9EA - Each68788-8679a409517b-47cc-4e73-8052-eda8f1f7bab812024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8679CELECOXIB CAPSULE [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 5 package rows20250221_b0839895-6a36-4e4f-9336-98632b60622a.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CelecoxibCELECOXIBREMEDYREPACK INC.c96509cc-47f4-44f8-9f7e-4e49cc3d53482026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210071
application number: ANDA210071
CelecoxibCELECOXIBA-S Medication Solutionse84d67c8-010d-495c-8691-ae16d0698f8d2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210071
application number: ANDA210071
CelecoxibCELECOXIBMullan Pharmaceutical Inc.643e177f-216d-4dfa-824a-7516a488304e2026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210071
application number: ANDA210071
CelecoxibCELECOXIBA-S Medication Solutionsd799328f-9ea0-4b64-9667-8feaa97f150c2026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210071
application number: ANDA210071
CelecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.b06ced10-81c6-4f48-a205-1e0db228cb8b2026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210071
application number: ANDA210071
CelecoxibCELECOXIBSt. Mary's Medical Park Pharmacy3bc74e76-0517-69c6-e063-6394a90abe752026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210071
application number: ANDA210071
CelecoxibCELECOXIBREMEDYREPACK INC.f5d0e5b9-97d8-42a4-a0a0-c09dde7008e62026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210071
application number: ANDA210071
CelecoxibCELECOXIBRedpharm Drug5250529a-6a03-78a1-e063-6294a90a47f92026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210071
application number: ANDA210071
CelecoxibCELECOXIBDirect_Rx4b2ffbdb-1847-d93b-e063-6394a90a06f52026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210071
application number: ANDA210071
CelecoxibCELECOXIBNorthwind Health Company, LLC0de7a6f8-baba-1fd0-e063-6394a90ad4342026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210071
application number: ANDA210071
CelecoxibCELECOXIBST. MARY'S MEDICAL PARK PHARMACY4e57bd99-5b7a-c2c7-e063-6294a90afb8c2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210071
application number: ANDA210071
CelecoxibCELECOXIBPreferred Pharmaceuticals Inc.b0839895-6a36-4e4f-9336-98632b60622a2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210071
application number: ANDA210071
ndc (package): 68788-8679-3
ndc (product): 68788-8679
ndc11 (package): 68788867903
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCeca923da-59fa-da2e-e053-2a95a90a6a512026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210071
application number: ANDA210071
CelecoxibCELECOXIBPreferred Pharmaceutical Inc.7f20976d-bed3-4a06-9aaf-f5b5240e4ce32026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210071
application number: ANDA210071
CelecoxibCELECOXIBProficient Rx LP3a450db8-313c-4120-9b8e-58c956323fa42025-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210071
application number: ANDA210071
CelecoxibCELECOXIBBryant Ranch Prepacka9749f00-0307-4842-a95b-9a8b4989df252025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210071
application number: ANDA210071
CelecoxibCELECOXIBCranbury Pharmaceuticals, LLC933532fa-044a-48b1-bbe4-28062564f98a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210071
application number: ANDA210071
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCf8fdcc56-7a53-9a42-e053-6394a90a48d52024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210071
application number: ANDA210071
CelecoxibCELECOXIBWestminster Pharmaceuticals, LLCcb0be640-067e-4422-9bec-d5fa07175bd02024-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210071
application number: ANDA210071
CelecoxibCELECOXIBA-S Medication Solutions85b87dd2-c609-4d69-99eb-0acd852acdaf2024-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210071
application number: ANDA210071

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNb0839895-6a36-4e4f-9336-98632b60622a3
205323celecoxib 200 MG Oral CapsuleSCDb0839895-6a36-4e4f-9336-98632b60622a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8679-36878886790330 CAPSULE in 1 BOTTLE (68788-8679-3) 30 capsule2024-05-29NoNoCurrent