Celecoxib

Product NDC
85766-009
11-digit product format
857660009
Labeler code
85766
Product ID
85766-009_4bdedcb2-33b7-6919-e063-6394a90a9563
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA205129
Marketing category
ANDA
Marketing start
2020-12-03
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
528a6f12-9878-4005-8fc2-5997adbb287fAvailable 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
85766-009-00Celecoxib1000 in 1 BOTTLECAPSULE10005
85766-009-01Celecoxib1 in 1 BOTTLECAPSULE15
85766-009-05Celecoxib500 in 1 BOTTLECAPSULE5005
85766-009-07Celecoxib7 in 1 BOTTLECAPSULE75
85766-009-09Celecoxib10 in 1 BOTTLECAPSULE105
85766-009-10Celecoxib100 in 1 BOTTLECAPSULE1005
85766-009-14Celecoxib14 in 1 BOTTLECAPSULE145
85766-009-20Celecoxib20 in 1 BOTTLECAPSULE205
85766-009-30Celecoxib30 in 1 BOTTLECAPSULE305
85766-009-60Celecoxib60 in 1 BOTTLECAPSULE605
85766-009-90Celecoxib90 in 1 BOTTLECAPSULE905

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
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
ndc (product): 85766-009
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 CapsulePSN528a6f12-9878-4005-8fc2-5997adbb287f5
205323celecoxib 200 MG Oral CapsuleSCD528a6f12-9878-4005-8fc2-5997adbb287f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-009-00857660009001000 CAPSULE in 1 BOTTLE (85766-009-00) 1000 capsule2025-06-20NoNoCurrent
85766-009-01857660009011 CAPSULE in 1 BOTTLE (85766-009-01) 1 capsule2025-06-20NoNoCurrent
85766-009-0585766000905500 CAPSULE in 1 BOTTLE (85766-009-05) 500 capsule2025-06-20NoNoCurrent
85766-009-07857660009077 CAPSULE in 1 BOTTLE (85766-009-07) 7 capsule2025-06-20NoNoCurrent
85766-009-098576600090910 CAPSULE in 1 BOTTLE (85766-009-09) 10 capsule2026-02-28NoNoCurrent
85766-009-1085766000910100 CAPSULE in 1 BOTTLE (85766-009-10) 100 capsule2025-06-20NoNoCurrent
85766-009-148576600091414 CAPSULE in 1 BOTTLE (85766-009-14) 14 capsule2025-06-20NoNoCurrent
85766-009-208576600092020 CAPSULE in 1 BOTTLE (85766-009-20) 20 capsule2025-06-20NoNoCurrent
85766-009-308576600093030 CAPSULE in 1 BOTTLE (85766-009-30) 30 capsule2025-06-20NoNoCurrent
85766-009-608576600096060 CAPSULE in 1 BOTTLE (85766-009-60) 60 capsule2025-06-20NoNoCurrent
85766-009-908576600099090 CAPSULE in 1 BOTTLE (85766-009-90) 90 capsule2025-06-20NoNoCurrent