celecoxib

Product NDC
50090-5638
11-digit product format
500905638
Labeler code
50090
Product ID
50090-5638_0d540a4e-27a4-4acc-b51c-5e6f9873dded
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202240
Marketing category
ANDA
Marketing start
2019-12-09
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
A202240-001CELECOXIBCELECOXIB50MGCAPSULE / ORALAB2014-10-29
A202240-002CELECOXIBCELECOXIB100MGCAPSULE / ORALAB2015-06-09
A202240-003CELECOXIBCELECOXIB200MGCAPSULE / ORALAB2015-06-09
A202240-004CELECOXIBCELECOXIB400MGCAPSULE / ORALAB2015-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202240-001AB
A202240-002AB
A202240-003AB
A202240-004AB

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 06:07:402026-07A202240-001CELECOXIB50MGCAPSULE / ORALAB2014-10-29caaa826d4ba7…
2026-08-18 06:07:402026-07A202240-002CELECOXIB100MGCAPSULE / ORALAB2015-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07A202240-003CELECOXIB200MGCAPSULE / ORALAB2015-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07A202240-004CELECOXIB400MGCAPSULE / ORALAB2015-06-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202240-001CELECOXIB50MGCAPSULE / ORALAB2014-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202240-002CELECOXIB100MGCAPSULE / ORALAB2015-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202240-003CELECOXIB200MGCAPSULE / ORALAB2015-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202240-004CELECOXIB400MGCAPSULE / ORALAB2015-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202240-001CELECOXIB50MGCAPSULE / ORALAB2014-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202240-002CELECOXIB100MGCAPSULE / ORALAB2015-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202240-003CELECOXIB200MGCAPSULE / ORALAB2015-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202240-004CELECOXIB400MGCAPSULE / ORALAB2015-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A202240-001CELECOXIB50MGCAPSULE / ORALAB2014-10-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202240-002CELECOXIB100MGCAPSULE / ORALAB2015-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202240-003CELECOXIB200MGCAPSULE / ORALAB2015-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202240-004CELECOXIB400MGCAPSULE / ORALAB2015-06-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202240-001CELECOXIB50MGCAPSULE / ORALAB2014-10-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202240-002CELECOXIB100MGCAPSULE / ORALAB2015-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202240-003CELECOXIB200MGCAPSULE / ORALAB2015-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202240-004CELECOXIB400MGCAPSULE / ORALAB2015-06-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202240-001CELECOXIB50MGCAPSULE / ORALAB2014-10-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202240-002CELECOXIB100MGCAPSULE / ORALAB2015-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202240-003CELECOXIB200MGCAPSULE / ORALAB2015-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202240-004CELECOXIB400MGCAPSULE / ORALAB2015-06-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202240-001CELECOXIB50MGCAPSULE / ORALAB2014-10-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202240-002CELECOXIB100MGCAPSULE / ORALAB2015-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202240-003CELECOXIB200MGCAPSULE / ORALAB2015-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202240-004CELECOXIB400MGCAPSULE / ORALAB2015-06-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202240-001CELECOXIB50MGCAPSULE / ORALAB2014-10-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202240-002CELECOXIB100MGCAPSULE / ORALAB2015-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202240-003CELECOXIB200MGCAPSULE / ORALAB2015-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202240-004CELECOXIB400MGCAPSULE / ORALAB2015-06-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202240-001CELECOXIB50MGCAPSULE / ORALAB2014-10-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202240-002CELECOXIB100MGCAPSULE / ORALAB2015-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202240-003CELECOXIB200MGCAPSULE / ORALAB2015-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202240-004CELECOXIB400MGCAPSULE / ORALAB2015-06-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202240-001CELECOXIB50MGCAPSULE / ORALAB2014-10-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202240-002CELECOXIB100MGCAPSULE / ORALAB2015-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202240-003CELECOXIB200MGCAPSULE / ORALAB2015-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202240-004CELECOXIB400MGCAPSULE / ORALAB2015-06-09d8e5a09893c0…

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 06:07:402026-07A202240-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202240-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202240-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202240-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202240-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202240-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202240-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202240-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202240-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202240-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202240-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202240-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202240-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202240-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202240-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202240-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202240-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202240-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202240-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202240-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202240-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202240-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202240-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202240-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202240-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202240-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202240-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202240-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202240-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202240-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202240-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202240-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202240-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202240-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202240-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202240-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202240-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202240-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202240-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202240-004AB1d8e5a09893c0…

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 · 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
85bfe02b-bfcb-44ee-81a0-11765c3054a9Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-5638-02023-02-06These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
50090-5638-12023-02-06These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
50090-5638-22023-02-06These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
50090-5638-02023-01-30These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
50090-5638-12023-01-30These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
50090-5638-22023-01-30These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5638-0celecoxib30 in 1 BOTTLECAPSULE303
50090-5638-1celecoxib60 in 1 BOTTLECAPSULE603
50090-5638-2celecoxib90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5638-0EA - Each50090-5638c7b779e3-376b-4495-abf0-1fb64e1af60b12022-12-07
50090-5638-1EA - Each50090-56382d279b38-b9c8-4d1b-b811-802ee0f6258f12022-10-06
50090-5638-2EA - Each50090-56386f99e486-6fc4-4010-8991-4d2d57243ceb12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5638CELECOXIB CAPSULE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 3 package rows20230208_85bfe02b-bfcb-44ee-81a0-11765c3054a9.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
celecoxibCELECOXIBLupin Pharmaceuticals, Inc.560017b1-daf8-464e-b86f-0a75c78002ec2023-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202240
application number: ANDA202240
celecoxibCELECOXIBA-S Medication Solutions85bfe02b-bfcb-44ee-81a0-11765c3054a92023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202240
application number: ANDA202240
ndc (product): 50090-5638

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN85bfe02b-bfcb-44ee-81a0-11765c3054a93
205323celecoxib 200 MG Oral CapsuleSCD85bfe02b-bfcb-44ee-81a0-11765c3054a93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5638-05009056380030 CAPSULE in 1 BOTTLE (50090-5638-0) 30 capsule2021-09-030000-00-00NoNoCurrent
50090-5638-15009056380160 CAPSULE in 1 BOTTLE (50090-5638-1) 60 capsule2021-09-030000-00-00NoNoCurrent
50090-5638-25009056380290 CAPSULE in 1 BOTTLE (50090-5638-2) 90 capsule2021-09-090000-00-00NoNoCurrent