Celecoxib
- Product NDC
- 62332-141
- 11-digit product format
- 623320141
- Labeler code
- 62332
- Product ID
- 62332-141_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
- 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
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204519-001 | CELECOXIB | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-08-21 | |
| A204519-002 | CELECOXIB | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-08-21 | |
| A204519-003 | CELECOXIB | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-08-21 | |
| A204519-004 | CELECOXIB | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-08-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204519-001 | AB |
| A204519-002 | AB |
| A204519-003 | AB |
| A204519-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A204519-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-08-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204519-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-08-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204519-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-08-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204519-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-08-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204519-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-08-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204519-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-08-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204519-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-08-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204519-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-08-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204519-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-08-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204519-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-08-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204519-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-08-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204519-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-08-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204519-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-08-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204519-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-08-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204519-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-08-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204519-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-08-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204519-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-08-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204519-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-08-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204519-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-08-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204519-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-08-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204519-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-08-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204519-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-08-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204519-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-08-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204519-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-08-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204519-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-08-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204519-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-08-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204519-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-08-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204519-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-08-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204519-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-08-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204519-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-08-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204519-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-08-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204519-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-08-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204519-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-08-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204519-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-08-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204519-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-08-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204519-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-08-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204519-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2015-08-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204519-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2015-08-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204519-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2015-08-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204519-004 | CELECOXIB | 400MG | CAPSULE / ORAL | AB | 2015-08-21 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A204519-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204519-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204519-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204519-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204519-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204519-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204519-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204519-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204519-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204519-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204519-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204519-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204519-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204519-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204519-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204519-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204519-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204519-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204519-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204519-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204519-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204519-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204519-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204519-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204519-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204519-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204519-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204519-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204519-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204519-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204519-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204519-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204519-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204519-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204519-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204519-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204519-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204519-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204519-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204519-004 | AB | 1 | d8e5a09893c0… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Celecoxib
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CELECOXIB | 100 mg/1 |
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 |
|---|---|---|---|---|---|---|
| 62332-141-08 | Celecoxib | 80 in 1 CARTON | CAPSULE | 80 | 14 | |
| 62332-141-30 | Celecoxib | 30 in 1 BOTTLE | CAPSULE | 30 | 14 | |
| 62332-141-31 | Celecoxib | 100 in 1 BOTTLE | CAPSULE | 100 | 14 | |
| 62332-141-60 | Celecoxib | 60 in 1 BOTTLE | CAPSULE | 60 | 14 | |
| 62332-141-71 | Celecoxib | 500 in 1 BOTTLE | CAPSULE | 500 | 14 | |
| 62332-141-91 | Celecoxib | 1000 in 1 BOTTLE | CAPSULE | 1000 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62332-141-31 | EA - Each | 62332-141 | 11e0f8c3-41b2-4d29-8e65-17558af9a53c | 1 | 2016-02-04 |
| 62332-141-71 | EA - Each | 62332-141 | fdfb636b-d8d9-43a1-9816-3be180324ac7 | 1 | 2019-10-07 |
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 | Alembic Pharmaceuticals Inc. | 806e5f8a-f986-4f88-ba3e-8265f86afa48 | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | 204519 ANDA204519 62332-141 |
| Celecoxib | CELECOXIB | Cardinal Health 107, LLC | a9114d6a-13d7-443c-be44-7866b4a4cf96 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | 204519 ANDA204519 |
| Celecoxib | CELECOXIB | AvPAK | 951df0f7-5fb7-40f5-e053-2995a90a1edd | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | 204519 ANDA204519 |
| Celecoxib | CELECOXIB | Major Pharmaceuticals | 3a1eadd5-c0a7-473e-bde0-6b9450d11c95 | 2026-04-06 | Boxed warning, Warnings, Adverse reactions | 204519 ANDA204519 |
| Celecoxib | CELECOXIB | RedPharm Drug | 2fbaa580-f33a-417d-e063-6294a90ad7df | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | 204519 ANDA204519 |
| Celecoxib | CELECOXIB | Alembic Pharmaceuticals Limited | 14e8d788-e44c-4a40-8678-25cf45fed477 | 2025-09-18 | Boxed warning, Warnings, Adverse reactions | 204519 ANDA204519 |
| Celecoxib 200 mg | CELECOXIB | Proficient Rx LP | feee6a01-63f9-42c3-8bd8-ca713a08b36d | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | 204519 ANDA204519 |
| Celecoxib | CELECOXIB | Proficient Rx LP | 7a234c0c-30a7-49f5-92a1-a1fc836ff9ae | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | 204519 ANDA204519 |
| Celecoxib | CELECOXIB | Proficient Rx LP | c787b0ab-77ab-4f7e-9fea-be2a0085020a | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | 204519 ANDA204519 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 62332-141-08 | 62332014108 | 80 CAPSULE in 1 CARTON (62332-141-08) | 80 capsule | 2015-12-01 | 0000-00-00 | No | No | Current |
| 62332-141-10 | 62332014110 | 100 CAPSULE in 1 CARTON (62332-141-10) | 100 capsule | 2015-12-01 | 0000-00-00 | No | No | Current |
| 62332-141-30 | 62332014130 | 30 CAPSULE in 1 BOTTLE (62332-141-30) | 30 capsule | 2015-12-01 | 0000-00-00 | No | No | Current |
| 62332-141-31 | 62332014131 | 100 CAPSULE in 1 BOTTLE (62332-141-31) | 100 capsule | 2015-12-01 | 0000-00-00 | No | No | Current |
| 62332-141-60 | 62332014160 | 60 CAPSULE in 1 BOTTLE (62332-141-60) | 60 capsule | 2015-12-01 | 0000-00-00 | No | No | Current |
| 62332-141-71 | 62332014171 | 500 CAPSULE in 1 BOTTLE (62332-141-71) | 500 capsule | 2015-12-01 | 0000-00-00 | No | No | Current |
| 62332-141-91 | 62332014191 | 1000 CAPSULE in 1 BOTTLE (62332-141-91) | 1000 capsule | 2015-12-01 | 0000-00-00 | No | No | Current |