Diclofenac sodium
- Product NDC
- 62332-487
- 11-digit product format
- 623320487
- Labeler code
- 62332
- Product ID
- 62332-487_9f0592a4-9652-4315-8f56-0774af4c5fb5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac sodium
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA212506
- Marketing category
- ANDA
- Marketing start
- 2022-11-29
- Substance
- DICLOFENAC SODIUM
- Active strength
- 20 mg/g
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DICLOFENAC SODIUM | 20 mg/g |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | QTG126297Q |
| Rxcui | 1487074 |
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 |
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| 8d368a34-1453-43ea-828d-0dbcd72b8794 | Product name | 8 | 20210622 |
| d6bab9d2-edce-a213-4796-226ab15472c3 | Product name | 6 | 20200616 |
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
| 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 |
|---|---|---|---|---|---|---|
| 62332-487-12 | Diclofenac sodium | 112 g in 1 BOTTLE, PUMP | SOLUTION | 112 | 9 | |
| 62332-487-12 | Diclofenac sodium | 1 in 1 CARTON | SOLUTION | 1 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62332-487-12 | GM - Gram | 62332-487 | 2743edb3-9e9d-4b3f-a45c-f8096bb75969 | 1 | 2023-02-06 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1487074 | diclofenac sodium 2 % Topical Solution | PSN | 02e90e33-384f-4e29-b508-2503def22214 | 9 |
| 1487074 | diclofenac sodium 20 MG/ML Topical Solution | SCD | 02e90e33-384f-4e29-b508-2503def22214 | 9 |
| 1487074 | diclofenac sodium 2 % Topical Solution | SY | 02e90e33-384f-4e29-b508-2503def22214 | 9 |
| 1487074 | diclofenac sodium 2 % Topical Solution | PSN | 3ee4c4e1-f23b-4d4a-bac7-59546d3a2c8b | 4 |
| 1487074 | diclofenac sodium 20 MG/ML Topical Solution | SCD | 3ee4c4e1-f23b-4d4a-bac7-59546d3a2c8b | 4 |
| 1487074 | diclofenac sodium 2 % Topical Solution | SY | 3ee4c4e1-f23b-4d4a-bac7-59546d3a2c8b | 4 |
| 1487074 | diclofenac sodium 2 % Topical Solution | PSN | fc0e1950-d76f-75bc-e053-6294a90a8c12 | 3 |
| 1487074 | diclofenac sodium 20 MG/ML Topical Solution | SCD | fc0e1950-d76f-75bc-e053-6294a90a8c12 | 3 |
| 1487074 | diclofenac sodium 2 % Topical Solution | SY | fc0e1950-d76f-75bc-e053-6294a90a8c12 | 3 |
| 1487074 | diclofenac sodium 2 % Topical Solution | PSN | 0416ce03-c345-9d9e-e063-6294a90ad940 | 2 |
| 1487074 | diclofenac sodium 20 MG/ML Topical Solution | SCD | 0416ce03-c345-9d9e-e063-6294a90ad940 | 2 |
| 1487074 | diclofenac sodium 2 % Topical Solution | SY | 0416ce03-c345-9d9e-e063-6294a90ad940 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 62332-487-12 | 62332048712 | 1 BOTTLE, PUMP in 1 CARTON (62332-487-12) / 112 g in 1 BOTTLE, PUMP | 2022-11-29 | 0000-00-00 | No | No | Current |