Celecoxib

Product NDC
11788-113
11-digit product format
117880113
Labeler code
11788
Product ID
11788-113_0978a0f1-be9d-4153-b9bc-9ab8652e8483
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
AiPing Pharmaceutical, Inc.
Application
ANDA208856
Marketing category
ANDA
Marketing start
2025-12-15
Substance
CELECOXIB
Active strength
100 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 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
A208856-001CELECOXIBCELECOXIB50MGCAPSULE / ORALAB2019-08-07
A208856-002CELECOXIBCELECOXIB100MGCAPSULE / ORALAB2019-08-07
A208856-003CELECOXIBCELECOXIB200MGCAPSULE / ORALAB2019-08-07
A208856-004CELECOXIBCELECOXIB400MGCAPSULE / ORALAB2019-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208856-001AB
A208856-002AB
A208856-003AB
A208856-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A208856-001CELECOXIB50MGCAPSULE / ORALAB2019-08-07caaa826d4ba7…
2026-08-18 06:07:402026-07A208856-002CELECOXIB100MGCAPSULE / ORALAB2019-08-07caaa826d4ba7…
2026-08-18 06:07:402026-07A208856-003CELECOXIB200MGCAPSULE / ORALAB2019-08-07caaa826d4ba7…
2026-08-18 06:07:402026-07A208856-004CELECOXIB400MGCAPSULE / ORALAB2019-08-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208856-001CELECOXIB50MGCAPSULE / ORALAB2019-08-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208856-002CELECOXIB100MGCAPSULE / ORALAB2019-08-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208856-003CELECOXIB200MGCAPSULE / ORALAB2019-08-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208856-004CELECOXIB400MGCAPSULE / ORALAB2019-08-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208856-001CELECOXIB50MGCAPSULE / ORALAB2019-08-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208856-002CELECOXIB100MGCAPSULE / ORALAB2019-08-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208856-003CELECOXIB200MGCAPSULE / ORALAB2019-08-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208856-004CELECOXIB400MGCAPSULE / ORALAB2019-08-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A208856-001CELECOXIB50MGCAPSULE / ORALAB2019-08-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208856-002CELECOXIB100MGCAPSULE / ORALAB2019-08-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208856-003CELECOXIB200MGCAPSULE / ORALAB2019-08-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208856-004CELECOXIB400MGCAPSULE / ORALAB2019-08-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208856-001CELECOXIB50MGCAPSULE / ORALAB2019-08-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208856-002CELECOXIB100MGCAPSULE / ORALAB2019-08-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208856-003CELECOXIB200MGCAPSULE / ORALAB2019-08-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208856-004CELECOXIB400MGCAPSULE / ORALAB2019-08-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208856-001CELECOXIB50MGCAPSULE / ORALAB2019-08-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208856-002CELECOXIB100MGCAPSULE / ORALAB2019-08-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208856-003CELECOXIB200MGCAPSULE / ORALAB2019-08-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208856-004CELECOXIB400MGCAPSULE / ORALAB2019-08-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208856-001CELECOXIB50MGCAPSULE / ORALAB2019-08-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208856-002CELECOXIB100MGCAPSULE / ORALAB2019-08-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208856-003CELECOXIB200MGCAPSULE / ORALAB2019-08-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208856-004CELECOXIB400MGCAPSULE / ORALAB2019-08-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208856-001CELECOXIB50MGCAPSULE / ORALAB2019-08-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208856-002CELECOXIB100MGCAPSULE / ORALAB2019-08-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208856-003CELECOXIB200MGCAPSULE / ORALAB2019-08-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208856-004CELECOXIB400MGCAPSULE / ORALAB2019-08-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208856-001CELECOXIB50MGCAPSULE / ORALAB2019-08-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208856-002CELECOXIB100MGCAPSULE / ORALAB2019-08-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208856-003CELECOXIB200MGCAPSULE / ORALAB2019-08-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208856-004CELECOXIB400MGCAPSULE / ORALAB2019-08-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208856-001CELECOXIB50MGCAPSULE / ORALAB2019-08-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208856-002CELECOXIB100MGCAPSULE / ORALAB2019-08-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208856-003CELECOXIB200MGCAPSULE / ORALAB2019-08-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208856-004CELECOXIB400MGCAPSULE / ORALAB2019-08-07d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A208856-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208856-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208856-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208856-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208856-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208856-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208856-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208856-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208856-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208856-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208856-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208856-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208856-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208856-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208856-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208856-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208856-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208856-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208856-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208856-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208856-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208856-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208856-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208856-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208856-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208856-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208856-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208856-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208856-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208856-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208856-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208856-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208856-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208856-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208856-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208856-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208856-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208856-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208856-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208856-004AB1d8e5a09893c0…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB100 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
89db0dec-3800-4d89-a765-24838f4d0c30Available 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
11788-113-01Celecoxib100 in 1 BOTTLECAPSULE1003
11788-113-05Celecoxib500 in 1 BOTTLECAPSULE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11788-113-01EA - Each11788-11349f555f2-99a7-4ee8-b6d5-72dfc403909d12026-02-05
11788-113-05EA - Each11788-1136f878ca8-b88d-4c5f-b3b4-32b052469f9a12026-02-05

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
CelecoxibCELECOXIBAiPing Pharmaceutical, Inc.89db0dec-3800-4d89-a765-24838f4d0c302026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208856
application number: ANDA208856
ndc (product): 11788-113
CELECOXIBCELECOXIBQingdao BAHEAL Pharmaceutical Co., Ltd.87c16a33-5eb0-40b0-a020-ed924326f6972026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208856
application number: ANDA208856

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN89db0dec-3800-4d89-a765-24838f4d0c303
205323celecoxib 200 MG Oral CapsulePSN89db0dec-3800-4d89-a765-24838f4d0c303
349514celecoxib 400 MG Oral CapsulePSN89db0dec-3800-4d89-a765-24838f4d0c303
686379celecoxib 50 MG Oral CapsulePSN89db0dec-3800-4d89-a765-24838f4d0c303
205322celecoxib 100 MG Oral CapsuleSCD89db0dec-3800-4d89-a765-24838f4d0c303
205323celecoxib 200 MG Oral CapsuleSCD89db0dec-3800-4d89-a765-24838f4d0c303
349514celecoxib 400 MG Oral CapsuleSCD89db0dec-3800-4d89-a765-24838f4d0c303
686379celecoxib 50 MG Oral CapsuleSCD89db0dec-3800-4d89-a765-24838f4d0c303

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11788-113-0111788011301100 CAPSULE in 1 BOTTLE (11788-113-01) 100 capsule2025-12-15NoNoCurrent
11788-113-0511788011305500 CAPSULE in 1 BOTTLE (11788-113-05) 500 capsule2025-12-15NoNoCurrent