Celecoxib

Product NDC
68788-8197
11-digit product format
687888197
Labeler code
68788
Product ID
68788-8197_b3a05107-8958-4473-8607-396a2c90081b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA205129
Marketing category
ANDA
Marketing start
2022-05-23
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 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
A205129-001CELECOXIBCELECOXIB50MGCAPSULE / ORALAB2020-12-03
A205129-002CELECOXIBCELECOXIB100MGCAPSULE / ORALAB2020-12-03
A205129-003CELECOXIBCELECOXIB200MGCAPSULE / ORALAB2020-12-03
A205129-004CELECOXIBCELECOXIB400MGCAPSULE / ORALAB2020-12-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205129-001AB
A205129-002AB
A205129-003AB
A205129-004AB

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 4 · 144 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A205129-001CELECOXIB50MGCAPSULE / ORALAB2020-12-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205129-002CELECOXIB100MGCAPSULE / ORALAB2020-12-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205129-003CELECOXIB200MGCAPSULE / ORALAB2020-12-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205129-004CELECOXIB400MGCAPSULE / ORALAB2020-12-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205129-001CELECOXIB50MGCAPSULE / ORALAB2020-12-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205129-002CELECOXIB100MGCAPSULE / ORALAB2020-12-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205129-003CELECOXIB200MGCAPSULE / ORALAB2020-12-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205129-004CELECOXIB400MGCAPSULE / ORALAB2020-12-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A205129-001CELECOXIB50MGCAPSULE / ORALAB2020-12-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205129-002CELECOXIB100MGCAPSULE / ORALAB2020-12-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205129-003CELECOXIB200MGCAPSULE / ORALAB2020-12-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205129-004CELECOXIB400MGCAPSULE / ORALAB2020-12-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205129-001CELECOXIB50MGCAPSULE / ORALAB2020-12-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205129-002CELECOXIB100MGCAPSULE / ORALAB2020-12-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205129-003CELECOXIB200MGCAPSULE / ORALAB2020-12-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205129-004CELECOXIB400MGCAPSULE / ORALAB2020-12-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205129-001CELECOXIB50MGCAPSULE / ORALAB2020-12-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205129-002CELECOXIB100MGCAPSULE / ORALAB2020-12-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205129-003CELECOXIB200MGCAPSULE / ORALAB2020-12-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205129-004CELECOXIB400MGCAPSULE / ORALAB2020-12-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205129-001CELECOXIB50MGCAPSULE / ORALAB2020-12-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205129-002CELECOXIB100MGCAPSULE / ORALAB2020-12-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205129-003CELECOXIB200MGCAPSULE / ORALAB2020-12-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205129-004CELECOXIB400MGCAPSULE / ORALAB2020-12-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205129-001CELECOXIB50MGCAPSULE / ORALAB2020-12-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205129-002CELECOXIB100MGCAPSULE / ORALAB2020-12-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205129-003CELECOXIB200MGCAPSULE / ORALAB2020-12-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205129-004CELECOXIB400MGCAPSULE / ORALAB2020-12-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205129-001CELECOXIB50MGCAPSULE / ORALAB2020-12-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205129-002CELECOXIB100MGCAPSULE / ORALAB2020-12-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205129-003CELECOXIB200MGCAPSULE / ORALAB2020-12-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205129-004CELECOXIB400MGCAPSULE / ORALAB2020-12-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205129-001CELECOXIB50MGCAPSULE / ORALAB2020-12-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205129-002CELECOXIB100MGCAPSULE / ORALAB2020-12-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205129-003CELECOXIB200MGCAPSULE / ORALAB2020-12-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205129-004CELECOXIB400MGCAPSULE / ORALAB2020-12-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205129-001CELECOXIB50MGCAPSULE / ORALAB2020-12-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A205129-002CELECOXIB100MGCAPSULE / ORALAB2020-12-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A205129-003CELECOXIB200MGCAPSULE / ORALAB2020-12-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A205129-004CELECOXIB400MGCAPSULE / ORALAB2020-12-03d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A205129-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205129-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205129-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205129-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205129-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205129-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205129-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205129-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205129-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205129-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205129-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205129-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205129-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205129-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205129-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205129-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205129-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205129-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205129-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205129-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205129-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205129-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205129-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205129-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205129-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205129-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205129-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205129-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205129-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205129-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205129-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205129-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205129-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205129-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205129-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205129-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205129-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205129-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205129-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205129-004AB1d06236e962d9…

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
f2a5ffbd-49c4-4a97-867b-2b14a3675020Available 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
68788-8197-1Celecoxib100 in 1 BOTTLECAPSULE1005
68788-8197-3Celecoxib30 in 1 BOTTLECAPSULE305
68788-8197-6Celecoxib60 in 1 BOTTLECAPSULE605
68788-8197-8Celecoxib120 in 1 BOTTLECAPSULE1205
68788-8197-9Celecoxib90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8197-1EA - Each68788-81970029dbca-fdae-4764-9ddc-aaeeadbf944512022-07-06
68788-8197-3EA - Each68788-819735244b8d-af9f-40e1-a11e-dbca6ea7577912022-07-06
68788-8197-6EA - Each68788-81971746cf30-36b6-4754-83c9-f71bee4ca7f712022-07-06
68788-8197-8EA - Each68788-8197ff0c3e15-6b51-49bd-a1a0-227648d54a0412022-07-06
68788-8197-9EA - Each68788-81974433b07e-5b7b-471e-8b4d-bc41f406ff9e12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8197CELECOXIB CAPSULE [PREFERRED PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 5 package rows20250221_f2a5ffbd-49c4-4a97-867b-2b14a3675020.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 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CelecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.06076494-62ad-4f58-b8bb-7038fcfe3b122026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBHAWAII REPACK, INC.77f3b90b-a25d-4c47-975a-2a988d696a3f2026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBSt Mary's Medical Park Pharmacye1ab644d-b668-3cf3-e053-2995a90addb02026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBRadha Pharmaceuticals, Inc.2c86ece8-1cf5-4688-91b1-8aef5d60b7e42026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBST. MARY'S MEDICAL PARK PHARMACYed2093f6-1606-100a-e053-2995a90a5b952026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBREMEDYREPACK INC.56127f57-7810-4f5d-a11d-e08fb2ed138b2026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBREMEDYREPACK INC.b3acbfd9-a1c2-4aa6-b5f0-013cfad6cca82026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBPreferred Pharmaceuticals, Inc.f2a5ffbd-49c4-4a97-867b-2b14a36750202026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
ndc (product): 68788-8197
CelecoxibCELECOXIBPreferred Pharmaceuticals, Inc.d35d9494-4190-41a8-80d4-c9d877c432e92026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBScieGen Pharmaceuticals, Inc.8709cbe7-3de1-4908-a0a9-53002bcee15b2026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBSportpharm LLC528a6f12-9878-4005-8fc2-5997adbb287f2026-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBPHOENIX RX LLC3a7b127e-c919-418f-e063-6394a90a06d02025-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBAsclemed USA, Inc.5d0dcac1-237c-47aa-bcfb-50fa20b5b8382025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBDirectRxe0f3aacf-df5d-dad7-e053-2995a90ac5eb2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBQuality Care Products, LLCfcf49d7f-8319-4051-b7ac-fe063268b39b2024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBBryant Ranch Prepack0d89c39e-4858-4255-9127-1366e005203c2024-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBBryant Ranch Prepack0dc9020d-28f5-4c69-896c-87b38e3ddb882024-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBBryant Ranch Prepack8a1e9a52-4627-4098-8a11-25e92ad960232024-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBNuCare Pharmaceuticals,Inc.dfdc74e8-1e4e-53e1-e053-2995a90abc522024-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLC15d6ef4f-568d-9d3e-e063-6294a90ab04c2024-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNf2a5ffbd-49c4-4a97-867b-2b14a36750205
205323celecoxib 200 MG Oral CapsuleSCDf2a5ffbd-49c4-4a97-867b-2b14a36750205

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8197-168788819701100 CAPSULE in 1 BOTTLE (68788-8197-1) 100 capsule2022-05-230000-00-00NoNoCurrent
68788-8197-36878881970330 CAPSULE in 1 BOTTLE (68788-8197-3) 30 capsule2022-05-230000-00-00NoNoCurrent
68788-8197-66878881970660 CAPSULE in 1 BOTTLE (68788-8197-6) 60 capsule2022-05-230000-00-00NoNoCurrent
68788-8197-868788819708120 CAPSULE in 1 BOTTLE (68788-8197-8) 120 capsule2022-05-230000-00-00NoNoCurrent
68788-8197-96878881970990 CAPSULE in 1 BOTTLE (68788-8197-9) 90 capsule2022-05-230000-00-00NoNoCurrent