Celecoxib
- Product NDC
- 72789-582
- 11-digit product format
- 727890582
- Labeler code
- 72789
- Product ID
- 72789-582_582b5e69-085b-ca7b-e063-6294a90ab93d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Celecoxib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA210071
- Marketing category
- ANDA
- Marketing start
- 2020-12-21
- Substance
- CELECOXIB
- Active strength
- 200 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents; Non-Steroidal [CS]; Cyclooxygenase Inhibitors [MoA]; Nonsteroidal Anti-inflammatory Drug [EPC]
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210071-001 | CELECOXIB | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-01-23 | |
| A210071-002 | CELECOXIB | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-01-23 | |
| A210071-003 | CELECOXIB | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-01-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210071-001 | AB |
| A210071-002 | AB |
| A210071-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210071-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-01-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210071-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-01-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210071-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-01-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210071-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-01-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210071-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-01-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210071-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-01-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210071-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-01-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210071-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-01-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210071-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-01-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210071-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-01-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210071-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-01-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210071-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-01-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210071-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-01-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210071-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-01-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210071-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-01-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210071-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-01-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210071-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-01-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210071-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-01-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210071-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-01-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210071-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-01-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210071-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-01-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210071-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-01-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210071-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-01-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210071-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-01-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210071-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-01-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210071-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-01-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210071-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-01-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210071-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-01-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210071-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-01-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210071-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-01-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210071-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-01-23 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210071-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-01-23 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210071-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-01-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210071-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-01-23 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210071-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-01-23 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210071-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-01-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210071-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-01-23 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210071-002 | CELECOXIB | 100MG | CAPSULE / ORAL | AB | 2018-01-23 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210071-003 | CELECOXIB | 200MG | CAPSULE / ORAL | AB | 2018-01-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210071-001 | CELECOXIB | 50MG | CAPSULE / ORAL | AB | 2018-01-23 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210071-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210071-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210071-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210071-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210071-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210071-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210071-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210071-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210071-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210071-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210071-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210071-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210071-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210071-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210071-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210071-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210071-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210071-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210071-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210071-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210071-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210071-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210071-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210071-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210071-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210071-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210071-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210071-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210071-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210071-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210071-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210071-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210071-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210071-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210071-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210071-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210071-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210071-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210071-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210071-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Celecoxib
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CELECOXIB | 200 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| JCX84Q7J1L | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b06ced10-81c6-4f48-a205-1e0db228cb8b | Available on FDA.report |
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 | St. Mary's Medical Park Pharmacy | 57b07096-6d7c-1653-e063-6294a90aa6e2 | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | 210071 ANDA210071 |
| Celecoxib | CELECOXIB | St. Mary's Medical Park Pharmacy | 3bc74e76-0517-69c6-e063-6394a90abe75 | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | 210071 ANDA210071 |
| Celecoxib | CELECOXIB | REMEDYREPACK INC. | f5d0e5b9-97d8-42a4-a0a0-c09dde7008e6 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | 210071 ANDA210071 |
| Celecoxib | CELECOXIB | Redpharm Drug | 5250529a-6a03-78a1-e063-6294a90a47f9 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 210071 ANDA210071 |
| Celecoxib | CELECOXIB | Direct_Rx | 4b2ffbdb-1847-d93b-e063-6394a90a06f5 | 2026-04-17 | Boxed warning, Warnings, Adverse reactions | 210071 ANDA210071 |
| Celecoxib | CELECOXIB | Northwind Health Company, LLC | 0de7a6f8-baba-1fd0-e063-6394a90ad434 | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | 210071 ANDA210071 |
| Celecoxib | CELECOXIB | ST. MARY'S MEDICAL PARK PHARMACY | 4e57bd99-5b7a-c2c7-e063-6294a90afb8c | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | 210071 ANDA210071 |
| Celecoxib | CELECOXIB | Preferred Pharmaceuticals Inc. | b0839895-6a36-4e4f-9336-98632b60622a | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | 210071 ANDA210071 |
| Celecoxib | CELECOXIB | Mullan Pharmaceutical Inc. | 643e177f-216d-4dfa-824a-7516a488304e | 2026-03-20 | Boxed warning, Warnings, Adverse reactions | 210071 ANDA210071 |
| Celecoxib | CELECOXIB | Advanced Rx Pharmacy of Tennessee, LLC | eca923da-59fa-da2e-e053-2a95a90a6a51 | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | 210071 ANDA210071 |
| Celecoxib | CELECOXIB | Preferred Pharmaceutical Inc. | 7f20976d-bed3-4a06-9aaf-f5b5240e4ce3 | 2026-03-18 | Boxed warning, Warnings, Adverse reactions | 210071 ANDA210071 |
| Celecoxib | CELECOXIB | REMEDYREPACK INC. | 7de31e90-2eaf-46cd-a058-3946b029d88c | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | 210071 ANDA210071 |
| Celecoxib | CELECOXIB | REMEDYREPACK INC. | c96509cc-47f4-44f8-9f7e-4e49cc3d5348 | 2025-09-26 | Boxed warning, Warnings, Adverse reactions | 210071 ANDA210071 |
| Celecoxib | CELECOXIB | Proficient Rx LP | 3a450db8-313c-4120-9b8e-58c956323fa4 | 2025-06-01 | Boxed warning, Warnings, Adverse reactions | 210071 ANDA210071 |
| Celecoxib | CELECOXIB | Bryant Ranch Prepack | a9749f00-0307-4842-a95b-9a8b4989df25 | 2025-02-03 | Boxed warning, Warnings, Adverse reactions | 210071 ANDA210071 |
| Celecoxib | CELECOXIB | Cranbury Pharmaceuticals, LLC | 933532fa-044a-48b1-bbe4-28062564f98a | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 210071 ANDA210071 |
| Celecoxib | CELECOXIB | Advanced Rx Pharmacy of Tennessee, LLC | f8fdcc56-7a53-9a42-e053-6394a90a48d5 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 210071 ANDA210071 |
| Celecoxib | CELECOXIB | Westminster Pharmaceuticals, LLC | cb0be640-067e-4422-9bec-d5fa07175bd0 | 2024-12-04 | Boxed warning, Warnings, Adverse reactions | 210071 ANDA210071 |
| Celecoxib | CELECOXIB | A-S Medication Solutions | 85b87dd2-c609-4d69-99eb-0acd852acdaf | 2024-08-21 | Boxed warning, Warnings, Adverse reactions | 210071 ANDA210071 |
| Celecoxib | CELECOXIB | NuCare Pharmaceuticals, Inc. | 1cbe21c0-3425-9a25-e063-6294a90a0d1d | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | 210071 ANDA210071 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Status |
|---|---|---|---|---|---|---|
| 72789-582-14 | 72789058214 | 14 CAPSULE in 1 BOTTLE, PLASTIC (72789-582-14) | 14 capsule | 2026-08-03 | 0 | Current |
| 72789-582-30 | 72789058230 | 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-582-30) | 30 capsule | 2026-08-03 | 0 | Current |
| 72789-582-60 | 72789058260 | 60 CAPSULE in 1 BOTTLE, PLASTIC (72789-582-60) | 60 capsule | 2026-08-03 | 0 | Current |