Diclofenac Sodium
- Product NDC
- 16571-201
- Requested package NDC
- 16571-201-11
- 11-digit product format
- 165710201
- Labeler code
- 16571
- Product ID
- 16571-201_504b1904-033c-4fd8-92c9-41e31154f808
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA077863
- Marketing category
- ANDA
- Marketing start
- 2008-08-19
- Substance
- DICLOFENAC SODIUM
- Active strength
- 75 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
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 16571-201 | 16571-201-11 | D | Discontinued by firm | excluded / ndc_excluded.zip | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 16571-201 | 16571-201-11 | D | Discontinued by firm | excluded / ndc_excluded.zip | a1b67e2a42f9… | c4cf2c586c0d… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077863-003 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077863-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 2007-06-08 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 2007-06-08 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 2007-06-08 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A077863-003 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | RS | 2007-06-08 | 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 | A077863-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077863-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077863-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077863-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077863-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077863-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077863-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077863-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077863-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077863-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077863-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077863-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077863-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077863-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077863-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077863-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077863-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077863-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077863-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077863-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A077863-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077863-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A077863-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A077863-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A077863-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A077863-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077863-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077863-003 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077863-003 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A077863-003 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A077863-003 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077863-003 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077863-003 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077863-003 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077863-003 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A077863-003 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A077863-003 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077863-003 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A077863-003 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A077863-003 | AB | 1 | e64feba35796… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diclofenac Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DICLOFENAC SODIUM | 75 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| QTG126297Q | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3330ea92-fc9d-4541-b378-be399b0995d3 | Available on FDA.report |
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 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 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 |
|---|---|---|---|---|---|---|
| 16571-201-06 | Diclofenac Sodium | 60 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 60 | 20 | |
| 16571-201-10 | Diclofenac Sodium | 100 in 1 BOTTLE | TABLET, DELAYED RELEASE | 100 | 20 | |
| 16571-201-11 | Diclofenac Sodium | 1000 in 1 BOTTLE | TABLET, DELAYED RELEASE | 1000 | 20 | |
| 16571-201-50 | Diclofenac Sodium | 500 in 1 BOTTLE | TABLET, DELAYED RELEASE | 500 | 20 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16571-201-06 | EA - Each | 16571-201 | c9085df3-78e2-4630-8f0c-5678d0cdf034 | 1 | 2012-07-24 |
| 16571-201-10 | EA - Each | 16571-201 | 3ea62e32-fada-4d1b-874c-fb10828e5c97 | 1 | 2012-07-24 |
| 16571-201-11 | EA - Each | 16571-201 | 7dd03004-479a-4f7d-baf4-31138f0fcf1f | 1 | 2012-07-24 |
| 16571-201-50 | EA - Each | 16571-201 | 035087fd-cbfd-4eb6-b4bf-f44f25cc1336 | 1 | 2012-07-24 |
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 |
|---|---|---|---|---|---|---|
| Diclofenac Sodium | DICLOFENAC SODIUM | PD-Rx Pharmaceuticals, Inc. | 681b6b25-4a28-44f2-8042-d5e01a502116 | 2026-08-12 | Boxed warning, Warnings, Adverse reactions | 077863 ANDA077863 |
| Diclofenac Sodium | DICLOFENAC SODIUM | American Health Packaging | dbb1489d-b690-4e53-905d-7fb07ad263b3 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | 077863 ANDA077863 |
| Diclofenac Sodium | DICLOFENAC SODIUM | St. Mary's Medical Park Pharmacy | 5f4b69de-8ddd-26c5-e053-2a91aa0ab326 | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | 077863 ANDA077863 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Proficient Rx LP | 1eb7a7bb-c524-4168-8ade-4601dc11533b | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | 077863 ANDA077863 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Preferred Pharmaceuticals Inc. | ed1b5ec7-2812-4a81-90d1-953baa0b0ec8 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | 077863 ANDA077863 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Asclemed USA, Inc. | 2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8 | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | 077863 ANDA077863 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Sportpharm LLC | e9ec5462-939a-4022-8946-5d81869a6277 | 2026-02-03 | Boxed warning, Warnings, Adverse reactions | 077863 ANDA077863 |
| Diclofenac Sodium | DICLOFENAC SODIUM | PHOENIX RX LLC | 47ce6fab-be1d-0076-e063-6294a90add63 | 2026-01-07 | Boxed warning, Warnings, Adverse reactions | 077863 ANDA077863 |
| Diclofenac Sodium | DICLOFENAC SODIUM | BluePoint Laboratories | feb1541a-de83-47dd-be03-c43376527318 | 2025-10-14 | Boxed warning, Warnings, Adverse reactions | 077863 ANDA077863 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Rising Pharma Holdings, Inc. | 3330ea92-fc9d-4541-b378-be399b0995d3 | 2025-08-05 | Boxed warning, Warnings, Adverse reactions | 077863 ANDA077863 16571-201-11 16571-201 16571020111 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Bryant Ranch Prepack | 487fa223-f4d9-4ab1-a5af-fb0d93f2bd0e | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | 077863 ANDA077863 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Coupler LLC | 2ce0741a-7bc7-8aec-e063-6294a90ae9ef | 2025-01-29 | Boxed warning, Warnings, Adverse reactions | 077863 ANDA077863 |
| Diclofenac Sodium | DICLOFENAC SODIUM | NuCare Pharmaceuticals,Inc. | 62edf474-9c16-d535-e053-2991aa0a4a09 | 2025-01-14 | Boxed warning, Warnings, Adverse reactions | 077863 ANDA077863 |
| Diclofenac DR | DICLOFENAC | Advanced Rx of Tennessee, LLC | af8a30fb-ead8-7e29-e053-2a95a90a040f | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 077863 ANDA077863 |
| Diclofenac Sodium | DICLOFENAC SODIUM | A-S Medication Solutions | 50efc183-dd3e-4eb7-ba5c-c42fd76e0b65 | 2023-12-25 | Boxed warning, Warnings, Adverse reactions | 077863 ANDA077863 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | PSN | bfa8cb40-3528-4d41-ae77-444e521e30c0 | 3981 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | bfa8cb40-3528-4d41-ae77-444e521e30c0 | 3981 |
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | SCD | bfa8cb40-3528-4d41-ae77-444e521e30c0 | 3981 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | bfa8cb40-3528-4d41-ae77-444e521e30c0 | 3981 |
| 855664 | diclofenac sodium 25 MG Delayed Release Oral Tablet | PSN | 3330ea92-fc9d-4541-b378-be399b0995d3 | 20 |
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | PSN | 3330ea92-fc9d-4541-b378-be399b0995d3 | 20 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 3330ea92-fc9d-4541-b378-be399b0995d3 | 20 |
| 855664 | diclofenac sodium 25 MG Delayed Release Oral Tablet | SCD | 3330ea92-fc9d-4541-b378-be399b0995d3 | 20 |
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | SCD | 3330ea92-fc9d-4541-b378-be399b0995d3 | 20 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 3330ea92-fc9d-4541-b378-be399b0995d3 | 20 |
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | PSN | 1e669fc2-69bf-4439-a336-a103e5b9cafe | 17 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 1e669fc2-69bf-4439-a336-a103e5b9cafe | 17 |
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | SCD | 1e669fc2-69bf-4439-a336-a103e5b9cafe | 17 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 1e669fc2-69bf-4439-a336-a103e5b9cafe | 17 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 5f4b69de-8ddd-26c5-e053-2a91aa0ab326 | 8 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | af8a30fb-ead8-7e29-e053-2a95a90a040f | 8 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 1eb7a7bb-c524-4168-8ade-4601dc11533b | 8 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 5f4b69de-8ddd-26c5-e053-2a91aa0ab326 | 8 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | af8a30fb-ead8-7e29-e053-2a95a90a040f | 8 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 1eb7a7bb-c524-4168-8ade-4601dc11533b | 8 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 487fa223-f4d9-4ab1-a5af-fb0d93f2bd0e | 5 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 62edf474-9c16-d535-e053-2991aa0a4a09 | 5 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | ed1b5ec7-2812-4a81-90d1-953baa0b0ec8 | 5 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | f0e00d55-02b7-4642-a60e-6a5841932ca5 | 5 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | ed1b5ec7-2812-4a81-90d1-953baa0b0ec8 | 5 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 62edf474-9c16-d535-e053-2991aa0a4a09 | 5 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 487fa223-f4d9-4ab1-a5af-fb0d93f2bd0e | 5 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | f0e00d55-02b7-4642-a60e-6a5841932ca5 | 5 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | e9ec5462-939a-4022-8946-5d81869a6277 | 4 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | e9ec5462-939a-4022-8946-5d81869a6277 | 4 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | e424b30d-8f40-48b7-bb99-415f92d84ed0 | 3 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 205a41d9-02b5-eb8b-e063-6394a90a0d8f | 3 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | e424b30d-8f40-48b7-bb99-415f92d84ed0 | 3 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 205a41d9-02b5-eb8b-e063-6394a90a0d8f | 3 |
| 855664 | diclofenac sodium 25 MG Delayed Release Oral Tablet | PSN | 2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8 | 2 |
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | PSN | 2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8 | 2 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 2c67e16a-9772-491e-a00f-8633451ca1bf | 2 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8 | 2 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 1b52cd67-bbc7-251f-e054-00144ff8d46c | 2 |
| 855664 | diclofenac sodium 25 MG Delayed Release Oral Tablet | SCD | 2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8 | 2 |
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | SCD | 2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8 | 2 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8 | 2 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 1b52cd67-bbc7-251f-e054-00144ff8d46c | 2 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 2c67e16a-9772-491e-a00f-8633451ca1bf | 2 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | eff16712-d4c4-4e7b-bf38-c467de1095f4 | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | f940aa00-2a88-44ce-b36f-fd51552b2c2b | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 50efc183-dd3e-4eb7-ba5c-c42fd76e0b65 | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 47ce6fab-be1d-0076-e063-6294a90add63 | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 3104cae3-5e36-6c6e-e054-00144ff88e88 | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 30627fe3-8720-7254-e054-00144ff88e88 | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 1b291d0a-1350-4637-bab3-f0bf43ab2a13 | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 50efc183-dd3e-4eb7-ba5c-c42fd76e0b65 | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 47ce6fab-be1d-0076-e063-6294a90add63 | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 3104cae3-5e36-6c6e-e054-00144ff88e88 | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | eff16712-d4c4-4e7b-bf38-c467de1095f4 | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 30627fe3-8720-7254-e054-00144ff88e88 | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | f940aa00-2a88-44ce-b36f-fd51552b2c2b | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 1b291d0a-1350-4637-bab3-f0bf43ab2a13 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 16571-201-11 | 16571020111 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-201-11) | 2008-08-19 | 0000-00-00 | No | No | Current |