Celecoxib
- Product NDC
- 0591-3984
- Requested package NDC
- 0591-3984-05
- 11-digit product format
- 005913984
- Labeler code
- 0591
- Product ID
- 0591-3984_42c5f4e4-5a65-4062-bf0a-b640659bc6f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Celecoxib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA200562
- Marketing category
- ANDA
- Marketing start
- 2015-03-12
- Marketing end
- 2026-12-31
- 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
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A200562-001 | CELECOXIB | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-02-11 | |
| A200562-002 | CELECOXIB | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-02-11 | |
| A200562-003 | CELECOXIB | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-02-11 | |
| A200562-004 | CELECOXIB | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-02-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A200562-001 | AB |
| A200562-002 | AB |
| A200562-003 | AB |
| A200562-004 | AB |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A200562-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-02-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A200562-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-02-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A200562-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-02-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A200562-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-02-11 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A200562-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-02-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A200562-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-02-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A200562-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-02-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A200562-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-02-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200562-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200562-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200562-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-02-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200562-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-02-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200562-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200562-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200562-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-02-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200562-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-02-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200562-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200562-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200562-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-02-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200562-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-02-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200562-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200562-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200562-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-02-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200562-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-02-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200562-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-02-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200562-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-02-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200562-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-02-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200562-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-02-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200562-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-02-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200562-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-02-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200562-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-02-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200562-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-02-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200562-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-02-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200562-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-02-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200562-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-02-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200562-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-02-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200562-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-02-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200562-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-02-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200562-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-02-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200562-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-02-11 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A200562-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A200562-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A200562-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A200562-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A200562-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A200562-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A200562-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A200562-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A200562-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200562-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200562-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200562-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200562-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200562-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200562-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200562-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A200562-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200562-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200562-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200562-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200562-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200562-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200562-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200562-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200562-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200562-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200562-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200562-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200562-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200562-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200562-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200562-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200562-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200562-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200562-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200562-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200562-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200562-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200562-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200562-004 | AB | 1 | 5bbf6a4d5a75… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Celecoxib
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CELECOXIB | 200 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| JCX84Q7J1L | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 05224473-27dc-4f6d-a52a-c40a7af2f2f4 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bff1fbab-f4cc-4993-b7de-2b555ee5eb73 | Product name | 1 | 20220509 |
| cc117a7e-1ef6-4866-90a7-ce0d190eef9a | Product name | 1 | 20200925 |
| 827beb42-45f2-95b8-6aa3-f35174375422 | Product name | 9 | 20160429 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0591-3984-01 | Celecoxib | 100 in 1 BOTTLE | CAPSULE | 100 | 21 | |
| 0591-3984-05 | Celecoxib | 500 in 1 BOTTLE | CAPSULE | 500 | 21 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-3984-01 | EA - Each | 0591-3984 | 2875a64a-55e2-4081-b612-f8a1bf412adc | 1 | 2015-05-05 |
| 0591-3984-05 | EA - Each | 0591-3984 | 0f93d6c5-7468-4ada-915a-d8034112a4f1 | 1 | 2015-05-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Celecoxib | CELECOXIB | Actavis Pharma, Inc. | 05224473-27dc-4f6d-a52a-c40a7af2f2f4 | 2025-04-30 | Boxed warning, Warnings, Adverse reactions | 200562 ANDA200562 0591-3984-05 0591-3984 00591398405 |
| Celecoxib | CELECOXIB | Asclemed USA, Inc. | 265b50cc-6d99-4ef8-8439-6792e1f21c68 | 2024-05-10 | Boxed warning, Warnings, Adverse reactions | 200562 ANDA200562 |
| Celecoxib | CELECOXIB | Proficient Rx LP | c529b321-38ed-434f-b76e-06902cdd40dc | 2023-12-01 | Boxed warning, Warnings, Adverse reactions | 200562 ANDA200562 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0591-3984-05 | 00591398405 | 500 CAPSULE in 1 BOTTLE (0591-3984-05) | 500 capsule | 2015-03-12 | 2026-12-31 | No | No | Current |