Diclofenac Sodium
- Product NDC
- 60290-082
- 11-digit product format
- 602900082
- Labeler code
- 60290
- Product ID
- 60290-082_499a6352-e243-abaf-e063-6394a90a8ae4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Umedica Laboratories USA Inc.
- Application
- ANDA219945
- Marketing category
- ANDA
- Marketing start
- 2026-02-15
- Substance
- DICLOFENAC SODIUM
- Active strength
- 25 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diclofenac Sodium
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DICLOFENAC SODIUM | 25 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 |
| 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 |
|---|---|---|---|---|---|---|
| 60290-082-01 | Diclofenac Sodium | 100 in 1 BOTTLE | TABLET, DELAYED RELEASE | 100 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60290-082-01 | EA - Each | 60290-082 | 4f11bef9-6966-4e69-8de2-2fbca603eabe | 1 | 2026-05-22 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 855664 | diclofenac sodium 25 MG Delayed Release Oral Tablet | PSN | 0e5c6669-390f-4c32-b9b8-13ed3c517462 | 6 |
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | PSN | 0e5c6669-390f-4c32-b9b8-13ed3c517462 | 6 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 0e5c6669-390f-4c32-b9b8-13ed3c517462 | 6 |
| 855664 | diclofenac sodium 25 MG Delayed Release Oral Tablet | SCD | 0e5c6669-390f-4c32-b9b8-13ed3c517462 | 6 |
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | SCD | 0e5c6669-390f-4c32-b9b8-13ed3c517462 | 6 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 0e5c6669-390f-4c32-b9b8-13ed3c517462 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 60290-082-01 | 60290008201 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-082-01) | 2026-02-15 | No | No | Current |