Diclofenac Sodium
- Product NDC
- 61442-226
- 11-digit product format
- 614420226
- Labeler code
- 61442
- Product ID
- 61442-226_363745c4-873f-ad20-e063-6394a90a8a84
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Carlsbad Technology, Inc.
- Application
- ANDA075185
- Marketing category
- ANDA
- Marketing start
- 2025-03-28
- Substance
- DICLOFENAC SODIUM
- Active strength
- 50 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075185-001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | |
| A075185-002 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | |
| A075185-003 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075185-001 | AB |
| A075185-002 | AB |
| A075185-003 | 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 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075185-002 | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075185-003 | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075185-001 | DICLOFENAC SODIUM | 75MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-11-13 | 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 | A075185-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075185-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075185-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075185-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075185-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075185-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075185-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075185-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075185-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075185-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075185-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075185-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075185-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075185-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075185-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075185-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075185-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075185-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075185-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075185-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diclofenac Sodium
- Brand name suffix
- Delayed Release
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DICLOFENAC SODIUM | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| QTG126297Q | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 363764a0-e0a8-3e3f-e063-6294a90ad672 | 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 |
|---|---|---|---|---|---|---|
| 61442-226-01 | Diclofenac SodiumDelayed Release | 100 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 100 | 1 | |
| 61442-226-01 | Diclofenac SodiumDelayed Release | 24 in 1 BOX | TABLET, DELAYED RELEASE | 24 | 1 | |
| 61442-226-10 | Diclofenac SodiumDelayed Release | 12 in 1 BOX | TABLET, DELAYED RELEASE | 12 | 1 | |
| 61442-226-10 | Diclofenac SodiumDelayed Release | 1000 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 1000 | 1 | |
| 61442-226-60 | Diclofenac SodiumDelayed Release | 24 in 1 BOX | TABLET, DELAYED RELEASE | 24 | 1 | |
| 61442-226-60 | Diclofenac SodiumDelayed Release | 60 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61442-226-01 | EA - Each | 61442-226 | 28bc0d88-f389-426f-83f4-0f7dfb58d142 | 1 | 2025-10-14 |
| 61442-226-10 | EA - Each | 61442-226 | 9b6ee97b-ed98-4981-8936-6187ebe759e1 | 1 | 2025-10-14 |
| 61442-226-60 | EA - Each | 61442-226 | d2605526-cb87-4471-a981-b227dcbe083f | 1 | 2025-10-14 |
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 Delayed Release | DICLOFENAC SODIUM | REMEDYREPACK INC. | ddd2278b-70be-41ca-8a84-e3fe0f1a1561 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | REMEDYREPACK INC. | 30c7e4fd-30af-4d28-a6ef-7386ff83cfb8 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | REMEDYREPACK INC. | 10991fe6-fafd-49af-9684-83b447c19c67 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium D/R | DICLOFENAC SODIUM D/R | DirectRx | 50886f90-8cd0-4d38-e063-6294a90a44e4 | 2026-04-28 | Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | REMEDYREPACK INC. | 7e940ce5-0f82-4d07-b507-c644481879c1 | 2026-04-22 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Preferred Pharmaceuticals Inc. | e947653c-6789-4c15-82c9-4b1402f6d6ac | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Redpharm Drug | 4cd2e51b-2019-6eb6-e063-6294a90ad7ef | 2026-03-12 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | A-S Medication Solutions | 0cefb675-c54e-44eb-b35c-38354b77eddd | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | A-S Medication Solutions | 74011b00-7e2e-40a7-ab30-c05a20559814 | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Golden State Medical Supply, Inc. | 468fab22-2b69-4a2c-e063-6294a90aab9a | 2026-01-27 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium | DICLOFENAC SODIUM | AvKARE | 19b4ff5c-adb7-a0d0-7ef2-4ae05047fd94 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | REMEDYREPACK INC. | 14c1b1a1-bc06-4722-9612-e88ae52272bc | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Northwind Health Company, LLC | c16e7e43-3869-9fef-e053-2995a90a1fdb | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Northwind Health Company, LLC | f2b7ea75-738b-54a8-e053-2995a90a00d5 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Advanced Rx of Tennessee, LLC | 47a7a294-55bb-8d19-e063-6394a90a5440 | 2025-12-31 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | A-S Medication Solutions | 40388047-7fbe-49bf-bed8-e5087bed4e03 | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | A-S Medication Solutions | 4a88f136-f7c7-47d7-b85d-8a2f9f118f09 | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | A-S Medication Solutions | 58063c26-86fe-4f03-97ef-51706e5f4054 | 2025-12-16 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Advanced Rx of Tennessee, LLC | 4539e9e7-5d82-3b36-e063-6394a90a1396 | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
| Diclofenac Sodium | DICLOFENAC SODIUM | SOLA Pharmaceuticals, LLC | b8072af2-9940-4827-9fbd-de46ad8bf929 | 2025-11-17 | Boxed warning, Warnings, Adverse reactions | 075185 ANDA075185 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 855664 | diclofenac sodium 25 MG Delayed Release Oral Tablet | PSN | 468fab22-2b69-4a2c-e063-6294a90aab9a | 2 |
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | PSN | 468fab22-2b69-4a2c-e063-6294a90aab9a | 2 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 468fab22-2b69-4a2c-e063-6294a90aab9a | 2 |
| 855664 | diclofenac sodium 25 MG Delayed Release Oral Tablet | SCD | 468fab22-2b69-4a2c-e063-6294a90aab9a | 2 |
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | SCD | 468fab22-2b69-4a2c-e063-6294a90aab9a | 2 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 468fab22-2b69-4a2c-e063-6294a90aab9a | 2 |
| 855664 | diclofenac sodium 25 MG Delayed Release Oral Tablet | PSN | 363764a0-e0a8-3e3f-e063-6294a90ad672 | 1 |
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | PSN | 0cefb675-c54e-44eb-b35c-38354b77eddd | 1 |
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | PSN | 74011b00-7e2e-40a7-ab30-c05a20559814 | 1 |
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | PSN | 50886f90-8cd0-4d38-e063-6294a90a44e4 | 1 |
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | PSN | 363764a0-e0a8-3e3f-e063-6294a90ad672 | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 363764a0-e0a8-3e3f-e063-6294a90ad672 | 1 |
| 855664 | diclofenac sodium 25 MG Delayed Release Oral Tablet | SCD | 363764a0-e0a8-3e3f-e063-6294a90ad672 | 1 |
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | SCD | 363764a0-e0a8-3e3f-e063-6294a90ad672 | 1 |
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | SCD | 50886f90-8cd0-4d38-e063-6294a90a44e4 | 1 |
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | SCD | 0cefb675-c54e-44eb-b35c-38354b77eddd | 1 |
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | SCD | 74011b00-7e2e-40a7-ab30-c05a20559814 | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 363764a0-e0a8-3e3f-e063-6294a90ad672 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 61442-226-01 | 61442022601 | 24 BOTTLE, PLASTIC in 1 BOX (61442-226-01) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | 2025-03-28 | No | No | Current |
| 61442-226-10 | 61442022610 | 12 BOTTLE, PLASTIC in 1 BOX (61442-226-10) / 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | 2025-03-28 | No | No | Current |
| 61442-226-60 | 61442022660 | 24 BOTTLE, PLASTIC in 1 BOX (61442-226-60) / 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | 2025-03-28 | No | No | Current |