Celecoxib

Product NDC
62332-142
11-digit product format
623320142
Labeler code
62332
Product ID
62332-142_0ae26abe-bbc0-48bf-b038-ca400ee197cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA204519
Marketing category
ANDA
Marketing start
2015-12-01
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
A204519-001CELECOXIBCELECOXIB50MGCAPSULE / ORALAB2015-08-21
A204519-002CELECOXIBCELECOXIB100MGCAPSULE / ORALAB2015-08-21
A204519-003CELECOXIBCELECOXIB200MGCAPSULE / ORALAB2015-08-21
A204519-004CELECOXIBCELECOXIB400MGCAPSULE / ORALAB2015-08-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204519-001AB
A204519-002AB
A204519-003AB
A204519-004AB

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 06:07:402026-07A204519-001CELECOXIB50MGCAPSULE / ORALAB2015-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07A204519-002CELECOXIB100MGCAPSULE / ORALAB2015-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07A204519-003CELECOXIB200MGCAPSULE / ORALAB2015-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07A204519-004CELECOXIB400MGCAPSULE / ORALAB2015-08-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204519-001CELECOXIB50MGCAPSULE / ORALAB2015-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204519-002CELECOXIB100MGCAPSULE / ORALAB2015-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204519-003CELECOXIB200MGCAPSULE / ORALAB2015-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204519-004CELECOXIB400MGCAPSULE / ORALAB2015-08-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204519-001CELECOXIB50MGCAPSULE / ORALAB2015-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204519-002CELECOXIB100MGCAPSULE / ORALAB2015-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204519-003CELECOXIB200MGCAPSULE / ORALAB2015-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204519-004CELECOXIB400MGCAPSULE / ORALAB2015-08-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204519-001CELECOXIB50MGCAPSULE / ORALAB2015-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204519-002CELECOXIB100MGCAPSULE / ORALAB2015-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204519-003CELECOXIB200MGCAPSULE / ORALAB2015-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204519-004CELECOXIB400MGCAPSULE / ORALAB2015-08-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204519-001CELECOXIB50MGCAPSULE / ORALAB2015-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204519-002CELECOXIB100MGCAPSULE / ORALAB2015-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204519-003CELECOXIB200MGCAPSULE / ORALAB2015-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204519-004CELECOXIB400MGCAPSULE / ORALAB2015-08-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204519-001CELECOXIB50MGCAPSULE / ORALAB2015-08-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204519-002CELECOXIB100MGCAPSULE / ORALAB2015-08-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204519-003CELECOXIB200MGCAPSULE / ORALAB2015-08-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204519-004CELECOXIB400MGCAPSULE / ORALAB2015-08-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204519-001CELECOXIB50MGCAPSULE / ORALAB2015-08-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204519-002CELECOXIB100MGCAPSULE / ORALAB2015-08-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204519-003CELECOXIB200MGCAPSULE / ORALAB2015-08-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204519-004CELECOXIB400MGCAPSULE / ORALAB2015-08-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204519-001CELECOXIB50MGCAPSULE / ORALAB2015-08-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204519-002CELECOXIB100MGCAPSULE / ORALAB2015-08-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204519-003CELECOXIB200MGCAPSULE / ORALAB2015-08-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204519-004CELECOXIB400MGCAPSULE / ORALAB2015-08-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204519-001CELECOXIB50MGCAPSULE / ORALAB2015-08-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204519-002CELECOXIB100MGCAPSULE / ORALAB2015-08-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204519-003CELECOXIB200MGCAPSULE / ORALAB2015-08-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204519-004CELECOXIB400MGCAPSULE / ORALAB2015-08-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204519-001CELECOXIB50MGCAPSULE / ORALAB2015-08-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204519-002CELECOXIB100MGCAPSULE / ORALAB2015-08-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204519-003CELECOXIB200MGCAPSULE / ORALAB2015-08-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204519-004CELECOXIB400MGCAPSULE / ORALAB2015-08-21d8e5a09893c0…

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 06:07:402026-07A204519-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204519-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204519-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204519-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204519-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204519-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204519-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204519-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204519-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204519-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204519-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204519-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204519-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204519-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204519-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204519-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204519-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204519-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204519-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204519-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204519-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204519-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204519-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204519-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204519-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204519-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204519-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204519-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204519-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204519-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204519-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204519-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204519-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204519-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204519-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204519-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204519-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204519-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204519-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204519-004AB1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
Celecoxib
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB200 mg/1

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
62332-142-08Celecoxib80 in 1 CARTONCAPSULE8014
62332-142-30Celecoxib30 in 1 BOTTLECAPSULE3014
62332-142-31Celecoxib100 in 1 BOTTLECAPSULE10014
62332-142-60Celecoxib60 in 1 BOTTLECAPSULE6014
62332-142-71Celecoxib500 in 1 BOTTLECAPSULE50014
62332-142-91Celecoxib1000 in 1 BOTTLECAPSULE100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-142-31EA - Each62332-14238733a71-8277-4144-aee3-da6296916a7612016-02-04
62332-142-71EA - Each62332-142df45db2f-2a08-4f10-9514-dfa5248b1d9812017-06-15
62332-142-91EA - Each62332-1428c3f2a98-3c9b-4d87-acfd-25e89ccf47e612016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-142CELECOXIB CAPSULE [ALEMBIC PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 6 package rows20250309_806e5f8a-f986-4f88-ba3e-8265f86afa48.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CelecoxibCELECOXIBAlembic Pharmaceuticals Inc.806e5f8a-f986-4f88-ba3e-8265f86afa482026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204519
application number: ANDA204519
ndc (product): 62332-142
CelecoxibCELECOXIBCardinal Health 107, LLCa9114d6a-13d7-443c-be44-7866b4a4cf962026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204519
application number: ANDA204519
CelecoxibCELECOXIBAvPAK951df0f7-5fb7-40f5-e053-2995a90a1edd2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204519
application number: ANDA204519
CelecoxibCELECOXIBMajor Pharmaceuticals3a1eadd5-c0a7-473e-bde0-6b9450d11c952026-04-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204519
application number: ANDA204519
CelecoxibCELECOXIBRedPharm Drug2fbaa580-f33a-417d-e063-6294a90ad7df2025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204519
application number: ANDA204519
CelecoxibCELECOXIBAlembic Pharmaceuticals Limited14e8d788-e44c-4a40-8678-25cf45fed4772025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204519
application number: ANDA204519
Celecoxib 200 mgCELECOXIBProficient Rx LPfeee6a01-63f9-42c3-8bd8-ca713a08b36d2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204519
application number: ANDA204519
CelecoxibCELECOXIBProficient Rx LP7a234c0c-30a7-49f5-92a1-a1fc836ff9ae2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204519
application number: ANDA204519
CelecoxibCELECOXIBProficient Rx LPc787b0ab-77ab-4f7e-9fea-be2a0085020a2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204519
application number: ANDA204519

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN806e5f8a-f986-4f88-ba3e-8265f86afa4814
205323celecoxib 200 MG Oral CapsulePSN806e5f8a-f986-4f88-ba3e-8265f86afa4814
349514celecoxib 400 MG Oral CapsulePSN806e5f8a-f986-4f88-ba3e-8265f86afa4814
686379celecoxib 50 MG Oral CapsulePSN806e5f8a-f986-4f88-ba3e-8265f86afa4814
205322celecoxib 100 MG Oral CapsuleSCD806e5f8a-f986-4f88-ba3e-8265f86afa4814
205323celecoxib 200 MG Oral CapsuleSCD806e5f8a-f986-4f88-ba3e-8265f86afa4814
349514celecoxib 400 MG Oral CapsuleSCD806e5f8a-f986-4f88-ba3e-8265f86afa4814
686379celecoxib 50 MG Oral CapsuleSCD806e5f8a-f986-4f88-ba3e-8265f86afa4814
205322celecoxib 100 MG Oral CapsulePSN951df0f7-5fb7-40f5-e053-2995a90a1edd6
205323celecoxib 200 MG Oral CapsulePSN951df0f7-5fb7-40f5-e053-2995a90a1edd6
205322celecoxib 100 MG Oral CapsuleSCD951df0f7-5fb7-40f5-e053-2995a90a1edd6
205323celecoxib 200 MG Oral CapsuleSCD951df0f7-5fb7-40f5-e053-2995a90a1edd6
205323celecoxib 200 MG Oral CapsulePSN81643e67-d6bd-4caf-a2d5-4993eeecd9c85
205323celecoxib 200 MG Oral CapsuleSCD81643e67-d6bd-4caf-a2d5-4993eeecd9c85
205323celecoxib 200 MG Oral CapsulePSNc787b0ab-77ab-4f7e-9fea-be2a0085020a3
205323celecoxib 200 MG Oral CapsulePSN2fbaa580-f33a-417d-e063-6294a90ad7df3
205323celecoxib 200 MG Oral CapsuleSCDc787b0ab-77ab-4f7e-9fea-be2a0085020a3
205323celecoxib 200 MG Oral CapsuleSCD2fbaa580-f33a-417d-e063-6294a90ad7df3
205322celecoxib 100 MG Oral CapsulePSN3a1eadd5-c0a7-473e-bde0-6b9450d11c951
205323celecoxib 200 MG Oral CapsulePSN3a1eadd5-c0a7-473e-bde0-6b9450d11c951
205323celecoxib 200 MG Oral CapsulePSN9add412e-3486-4097-e053-2995a90a8fc71
205323celecoxib 200 MG Oral CapsulePSNbbf509e1-a8c2-56b8-e053-2995a90ae5c71
205322celecoxib 100 MG Oral CapsuleSCD3a1eadd5-c0a7-473e-bde0-6b9450d11c951
205323celecoxib 200 MG Oral CapsuleSCD3a1eadd5-c0a7-473e-bde0-6b9450d11c951
205323celecoxib 200 MG Oral CapsuleSCD9add412e-3486-4097-e053-2995a90a8fc71
205323celecoxib 200 MG Oral CapsuleSCDbbf509e1-a8c2-56b8-e053-2995a90ae5c71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-142-086233201420880 CAPSULE in 1 CARTON (62332-142-08) 80 capsule2015-12-010000-00-00NoNoCurrent
62332-142-1062332014210100 CAPSULE in 1 CARTON (62332-142-10) 100 capsule2015-12-010000-00-00NoNoCurrent
62332-142-306233201423030 CAPSULE in 1 BOTTLE (62332-142-30) 30 capsule2015-12-010000-00-00NoNoCurrent
62332-142-3162332014231100 CAPSULE in 1 BOTTLE (62332-142-31) 100 capsule2015-12-010000-00-00NoNoCurrent
62332-142-606233201426060 CAPSULE in 1 BOTTLE (62332-142-60) 60 capsule2015-12-010000-00-00NoNoCurrent
62332-142-7162332014271500 CAPSULE in 1 BOTTLE (62332-142-71) 500 capsule2015-12-010000-00-00NoNoCurrent
62332-142-91623320142911000 CAPSULE in 1 BOTTLE (62332-142-91) 1000 capsule2015-12-010000-00-00NoNoCurrent