CELECOXIB

Product NDC
42571-144
11-digit product format
425710144
Labeler code
42571
Product ID
42571-144_350160e1-34ab-f7e3-e063-6394a90a4508
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA204776
Marketing category
ANDA
Marketing start
2018-06-01
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
2026-12-31
Current FDA listing
Yes

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

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
A204776-001CELECOXIBCELECOXIB50MGCAPSULE / ORALAB2018-04-30
A204776-002CELECOXIBCELECOXIB100MGCAPSULE / ORALAB2018-04-30
A204776-003CELECOXIBCELECOXIB200MGCAPSULE / ORALAB2018-04-30
A204776-004CELECOXIBCELECOXIB400MGCAPSULE / ORALAB2018-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204776-001AB
A204776-002AB
A204776-003AB
A204776-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-30d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A204776-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204776-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204776-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204776-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204776-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204776-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204776-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204776-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204776-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204776-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204776-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204776-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-004AB1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
CELECOXIB
Listing expiration
2026-12-31

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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
205322Internal RxNorm lookup
205323Internal RxNorm lookup
349514Internal RxNorm lookup
686379Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
408b30d6-f5c2-4239-b993-d8f77a8e160bAvailable 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
42571-144-01CELECOXIB100 in 1 BOTTLECAPSULE10016
42571-144-05CELECOXIB500 in 1 BOTTLECAPSULE50016
42571-144-29CELECOXIB6 in 1 CARTONCAPSULE616
42571-144-30CELECOXIB30 in 1 BOTTLECAPSULE3016
42571-144-32CELECOXIB10 in 1 BLISTER PACKCAPSULE1016
42571-144-60CELECOXIB60 in 1 BOTTLECAPSULE6016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-144-01EA - Each42571-1442a2372a2-5c1c-4cf2-8837-d6d04f58a85912019-01-24
42571-144-05EA - Each42571-144624d2ea5-58ad-4990-a99f-bdb6cb76ec6512018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-144CELECOXIB (CELECOXIB) CAPSULE [MICRO LABS LIMITED]16Current NDC, Legacy NDC, 6 package rows20250515_408b30d6-f5c2-4239-b993-d8f77a8e160b.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CELECOXIBCELECOXIBAmerican Health Packaging4af52ae3-6b9d-4bc9-ad6b-c983e4c9dcc72026-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CELECOXIBCELECOXIBNorthwind Health Company, LLCdabfb290-0a7f-3429-e053-2a95a90ae04c2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CELECOXIBCELECOXIBNorthwind Health Company, LLCdac05189-4acf-d6bb-e053-2a95a90a46a92026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CELECOXIBCELECOXIBMicro Labs Limited408b30d6-f5c2-4239-b993-d8f77a8e160b2025-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
ndc (product): 42571-144
CELECOXIBCELECOXIBBryant Ranch Prepack550c828b-8c88-4c47-a7b8-a436aed46dc72025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CELECOXIBCELECOXIBBryant Ranch Prepackdeeecba5-7a76-444b-a891-b00b1fb16d512025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CelecoxibCELECOXIBAdvanced Rx of Tennessee, LLCaf9da1f2-717b-32b6-e053-2995a90ae5852024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CELECOXIBCELECOXIBProficient Rx LP1071fcb5-0e9f-4e30-8fb4-df76fd876fe82024-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CELECOXIBCELECOXIBBryant Ranch Prepack627abea5-e39a-4e4f-b1ab-4842ed8112e92024-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CELECOXIBCELECOXIBA-S Medication Solutions00e67d5e-df6f-4dfd-8c2d-a001c8a99af02023-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CELECOXIBCELECOXIBA-S Medication Solutionsc7a183dc-f4d5-483f-964c-f2745a3640ad2023-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN627abea5-e39a-4e4f-b1ab-4842ed8112e9102
205323celecoxib 200 MG Oral CapsuleSCD627abea5-e39a-4e4f-b1ab-4842ed8112e9102
205322celecoxib 100 MG Oral CapsulePSN408b30d6-f5c2-4239-b993-d8f77a8e160b16
205323celecoxib 200 MG Oral CapsulePSN408b30d6-f5c2-4239-b993-d8f77a8e160b16
349514celecoxib 400 MG Oral CapsulePSN408b30d6-f5c2-4239-b993-d8f77a8e160b16
686379celecoxib 50 MG Oral CapsulePSN408b30d6-f5c2-4239-b993-d8f77a8e160b16
205322celecoxib 100 MG Oral CapsuleSCD408b30d6-f5c2-4239-b993-d8f77a8e160b16
205323celecoxib 200 MG Oral CapsuleSCD408b30d6-f5c2-4239-b993-d8f77a8e160b16
349514celecoxib 400 MG Oral CapsuleSCD408b30d6-f5c2-4239-b993-d8f77a8e160b16
686379celecoxib 50 MG Oral CapsuleSCD408b30d6-f5c2-4239-b993-d8f77a8e160b16
205323celecoxib 200 MG Oral CapsulePSNdeeecba5-7a76-444b-a891-b00b1fb16d5110
205323celecoxib 200 MG Oral CapsuleSCDdeeecba5-7a76-444b-a891-b00b1fb16d5110
205323celecoxib 200 MG Oral CapsulePSN00e67d5e-df6f-4dfd-8c2d-a001c8a99af09
205323celecoxib 200 MG Oral CapsuleSCD00e67d5e-df6f-4dfd-8c2d-a001c8a99af09
205323celecoxib 200 MG Oral CapsulePSNaf9da1f2-717b-32b6-e053-2995a90ae5857
205323celecoxib 200 MG Oral CapsuleSCDaf9da1f2-717b-32b6-e053-2995a90ae5857
205322celecoxib 100 MG Oral CapsulePSN4af52ae3-6b9d-4bc9-ad6b-c983e4c9dcc76
205323celecoxib 200 MG Oral CapsulePSN4af52ae3-6b9d-4bc9-ad6b-c983e4c9dcc76
205322celecoxib 100 MG Oral CapsuleSCD4af52ae3-6b9d-4bc9-ad6b-c983e4c9dcc76
205323celecoxib 200 MG Oral CapsuleSCD4af52ae3-6b9d-4bc9-ad6b-c983e4c9dcc76
205323celecoxib 200 MG Oral CapsulePSNdac05189-4acf-d6bb-e053-2a95a90a46a94
205323celecoxib 200 MG Oral CapsuleSCDdac05189-4acf-d6bb-e053-2a95a90a46a94
205323celecoxib 200 MG Oral CapsulePSN65cb4362-f034-406e-a118-a09cfd44e2da3
205323celecoxib 200 MG Oral CapsuleSCD65cb4362-f034-406e-a118-a09cfd44e2da3
205323celecoxib 200 MG Oral CapsulePSN67c6ea14-efbb-40b0-ab53-fddaa30204c62
205323celecoxib 200 MG Oral CapsuleSCD67c6ea14-efbb-40b0-ab53-fddaa30204c62
205323celecoxib 200 MG Oral CapsulePSN9af06651-d73b-2269-e053-2a95a90a1c561
205323celecoxib 200 MG Oral CapsuleSCD9af06651-d73b-2269-e053-2a95a90a1c561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-144-0142571014401100 CAPSULE in 1 BOTTLE (42571-144-01) 100 capsule2018-06-010000-00-00NoNoCurrent
42571-144-0542571014405500 CAPSULE in 1 BOTTLE (42571-144-05) 500 capsule2018-06-010000-00-00NoNoCurrent
42571-144-29425710144296 BLISTER PACK in 1 CARTON (42571-144-29) / 10 CAPSULE in 1 BLISTER PACK (42571-144-32) 6 blister pack2018-06-010000-00-00NoNoCurrent
42571-144-304257101443030 CAPSULE in 1 BOTTLE (42571-144-30) 30 capsule2018-06-010000-00-00NoNoCurrent
42571-144-324257101443210 in 1 BLISTER PACKHistorical
42571-144-604257101446060 CAPSULE in 1 BOTTLE (42571-144-60) 60 capsule2018-06-010000-00-00NoNoCurrent