Diclofenac Sodium
- Product NDC
- 61442-227
- 11-digit product format
- 614420227
- Labeler code
- 61442
- Product ID
- 61442-227_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
- 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
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 | 75 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | QTG126297Q |
| Rxcui | 855664, 855906, 855926 |
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 |
|---|---|---|---|---|---|---|
| 61442-227-01 | Diclofenac SodiumDelayed Release | 100 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 100 | 1 | |
| 61442-227-05 | Diclofenac SodiumDelayed Release | 500 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 500 | 1 | |
| 61442-227-10 | Diclofenac SodiumDelayed Release | 1000 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 1000 | 1 | |
| 61442-227-60 | Diclofenac SodiumDelayed Release | 60 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 60 | 1 |
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 | 363764a0-e0a8-3e3f-e063-6294a90ad672 | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 363764a0-e0a8-3e3f-e063-6294a90ad672 | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 7e940ce5-0f82-4d07-b507-c644481879c1 | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 4cd2e51b-2019-6eb6-e063-6294a90ad7ef | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 40388047-7fbe-49bf-bed8-e5087bed4e03 | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 4a88f136-f7c7-47d7-b85d-8a2f9f118f09 | 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 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 4a88f136-f7c7-47d7-b85d-8a2f9f118f09 | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 4cd2e51b-2019-6eb6-e063-6294a90ad7ef | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 40388047-7fbe-49bf-bed8-e5087bed4e03 | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 363764a0-e0a8-3e3f-e063-6294a90ad672 | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 7e940ce5-0f82-4d07-b507-c644481879c1 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 61442-227-01 | 61442022701 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-227-01) | 2025-03-28 | No | No | Current |
| 61442-227-05 | 61442022705 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-227-05) | 2025-03-28 | No | No | Current |
| 61442-227-10 | 61442022710 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-227-10) | 2025-03-28 | No | No | Current |
| 61442-227-60 | 61442022760 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-227-60) | 2025-03-28 | No | No | Current |