Diclofenac Sodium
- Product NDC
- 71335-1238
- 11-digit product format
- 713351238
- Labeler code
- 71335
- Product ID
- 71335-1238_72d96aa7-bd3d-44e0-98cf-b65a738221d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA076201
- Marketing category
- ANDA
- Marketing start
- 2002-11-06
- Substance
- DICLOFENAC SODIUM
- Active strength
- 100 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 71335-1238 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 71335-1238 | 71335-1238-1 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 71335-1238 | 71335-1238-2 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 71335-1238 | 71335-1238-3 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 71335-1238 | 71335-1238-4 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 71335-1238 | 71335-1238-5 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 71335-1238 | 71335-1238-6 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 71335-1238 | 71335-1238-7 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 71335-1238 | 71335-1238-8 | D | Discontinued by firm | 2026-08-17 | |
| excluded package | package | 71335-1238 | 71335-1238-9 | D | Discontinued by firm | 2026-08-17 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076201-001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076201-001 | 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 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A076201-001 | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2002-11-06 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076201-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076201-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076201-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076201-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076201-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076201-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076201-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076201-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076201-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076201-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076201-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076201-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076201-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076201-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076201-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076201-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076201-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076201-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076201-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A076201-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A076201-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076201-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A076201-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A076201-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A076201-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A076201-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A076201-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A076201-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076201-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A076201-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A076201-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076201-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076201-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076201-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076201-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A076201-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A076201-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076201-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A076201-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A076201-001 | AB | 1 | e64feba35796… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 111d457e-3138-4512-b0ba-d0cd760c4055 | Product name | 3 | 20250225 |
| 0426261e-1bb9-b78b-abd2-80da765a7e3e | Product name | 2 | 20240513 |
| 7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7 | Product name | 5 | 20240320 |
| 0ac2f11f-f58d-baf2-71a0-680993b48a61 | Product name | 2 | 20231211 |
| 855d63c3-b090-4636-8fc7-6d39ad23c44f | Product name | 1 | 20230829 |
| bb58f410-04be-65dd-9211-e89ead899698 | Product name | 6 | 20230323 |
| 0fcbc38a-8b29-3348-1cef-5222ea53484f | Product name | 4 | 20220516 |
| c4e1eedc-aca2-4551-8382-89144ed9d049 | Product name | 3 | 20220126 |
| 8d368a34-1453-43ea-828d-0dbcd72b8794 | Product name | 8 | 20210622 |
| d6bab9d2-edce-a213-4796-226ab15472c3 | Product name | 6 | 20200616 |
| 2487e6ef-d419-42fc-aaf8-7acc805d2370 | Product name | 2 | 20170718 |
| e071c814-e5e7-e7ed-ec76-428765d9c66b | Product name | 2 | 20151120 |
| 93148e06-b8d7-4e6c-853e-62f807d17fbb | Product name | 1 | 20151014 |
| dbb00be6-fb1c-4b0a-a770-31f7e05e247e | Product name | 1 | 20150316 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71335-1238-1 | Diclofenac Sodium | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | 5 | |
| 71335-1238-2 | Diclofenac Sodium | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 5 | |
| 71335-1238-3 | Diclofenac Sodium | 15 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 15 | 5 | |
| 71335-1238-4 | Diclofenac Sodium | 14 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 14 | 5 | |
| 71335-1238-5 | Diclofenac Sodium | 10 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 10 | 5 | |
| 71335-1238-6 | Diclofenac Sodium | 21 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 21 | 5 | |
| 71335-1238-7 | Diclofenac Sodium | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | 5 | |
| 71335-1238-8 | Diclofenac Sodium | 120 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 120 | 5 | |
| 71335-1238-9 | Diclofenac Sodium | 7 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 7 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71335-1238-1 | EA - Each | 71335-1238 | 5a3c9457-cfc0-458b-b007-0392d1ef0dea | 1 | 2019-11-12 |
| 71335-1238-2 | EA - Each | 71335-1238 | 41d8792e-83ba-4cd8-a074-a9f7832aaab6 | 1 | 2023-12-05 |
| 71335-1238-4 | EA - Each | 71335-1238 | 10e03210-f8bb-4b12-af7c-ba4528cfbd0c | 1 | 2023-12-05 |
| 71335-1238-5 | EA - Each | 71335-1238 | 69e6c5a4-7172-4e6e-b1bc-cc123fb56a0d | 1 | 2023-12-05 |
| 71335-1238-6 | EA - Each | 71335-1238 | 0492b843-12ec-492a-8e93-291040034234 | 1 | 2020-09-14 |
| 71335-1238-9 | EA - Each | 71335-1238 | 094e29d9-ad19-44a7-b33f-74c00d4d720b | 1 | 2023-12-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71335-1238 | DICLOFENAC SODIUM TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 5 | Current NDC, Legacy NDC, 9 package rows | 20231108_e9ece848-3cd3-4a75-be88-d131775016a7.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Diclofenac Sodium | DICLOFENAC SODIUM | ST. MARY'S MEDICAL PARK PHARMACY | 4ddd7e34-e5f4-8f05-e063-6294a90a70aa | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | 076201 ANDA076201 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Edenbridge Pharmaceuticals LLC. | bd25a2b1-a4d5-4893-97d1-efdcd414a97d | 2026-02-25 | Boxed warning, Warnings, Adverse reactions | 076201 ANDA076201 |
| Diclofenac Sodium | DICLOFENAC SODIUM | NuCare Pharmaceuticals,Inc. | 0d1d19e5-4ffe-af95-e063-6394a90a7abf | 2025-02-03 | Boxed warning, Warnings, Adverse reactions | 076201 ANDA076201 |
| Diclofenac Sodium | DICLOFENAC SODIUM | NuCare Pharmaceuticals, LLC. | 26e44aa5-cfcd-f10b-e063-6394a90a4dcf | 2024-11-14 | Boxed warning, Warnings, Adverse reactions | 076201 ANDA076201 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 855657 | diclofenac sodium 100 MG 24HR Extended Release Oral Tablet | PSN | e9ece848-3cd3-4a75-be88-d131775016a7 | 5 |
| 855657 | 24 HR diclofenac sodium 100 MG Extended Release Oral Tablet | SCD | e9ece848-3cd3-4a75-be88-d131775016a7 | 5 |
| 855657 | diclofenac sodium 100 MG 24 HR Extended Release Oral Tablet | SY | e9ece848-3cd3-4a75-be88-d131775016a7 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71335-1238-1 | 71335123801 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-1) | 2019-06-03 | 0000-00-00 | No | No | Current |
| 71335-1238-2 | 71335123802 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-2) | 2021-04-28 | 0000-00-00 | No | No | Current |
| 71335-1238-3 | 71335123803 | 15 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-3) | 2022-06-29 | 0000-00-00 | No | No | Current |
| 71335-1238-4 | 71335123804 | 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-4) | 2021-07-12 | 0000-00-00 | No | No | Current |
| 71335-1238-5 | 71335123805 | 10 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-5) | 2021-08-30 | 0000-00-00 | No | No | Current |
| 71335-1238-6 | 71335123806 | 21 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-6) | 2019-09-03 | 0000-00-00 | No | No | Current |
| 71335-1238-7 | 71335123807 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-7) | 2022-06-29 | 0000-00-00 | No | No | Current |
| 71335-1238-8 | 71335123808 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-8) | 2022-06-29 | 0000-00-00 | No | No | Current |
| 71335-1238-9 | 71335123809 | 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-9) | 2022-05-27 | 0000-00-00 | No | No | Current |