Profinac
- Product NDC
- 73516-450
- 11-digit product format
- 735160450
- Labeler code
- 73516
- Product ID
- 73516-450_29304ad1-341a-4e8a-bbe5-cc80a23a98fe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- KIT
- Labeler
- Ashoka Health
- Application
- ANDA204132
- Marketing category
- ANDA
- Marketing start
- 2022-02-01
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 73516-450-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1065-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL SOLUTION safely and effectively. See Full Prescribing Information for DICLOFENAC SODIUM TOPICAL SOLUTION. DICLOFENAC SODIUM topical solution. Initial U.S. Approval: 1988 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70512-038-05 | Profinac | 150 mL in 1 BOTTLE | SOLUTION | 150 mL | 16.05 mg in 1mL | 1 |
| 70512-038-05 | Profinac | 1 in 1 CARTON | SOLUTION | 16.05 mg in 1mL | 1 | |
| 73516-450-01 | Profinac | 1 in 1 CARTON | KIT | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 73516-450-01 | EA - Each | 73516-450 | f9baca9e-e4de-4537-8975-3bde6ad380a8 | 1 | 2022-03-09 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 857700 | diclofenac sodium 1.5 % Topical Solution | PSN | e1dce228-1b5b-4350-b1d1-c2960a9b4273 | 1 |
| 857700 | diclofenac sodium 15 MG/ML Topical Solution | SCD | e1dce228-1b5b-4350-b1d1-c2960a9b4273 | 1 |
| 857700 | diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution | SY | e1dce228-1b5b-4350-b1d1-c2960a9b4273 | 1 |
| 857700 | diclofenac sodium 16.05 MG per 1 ML Topical Solution | SY | e1dce228-1b5b-4350-b1d1-c2960a9b4273 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70512-038-05 | 70512003805 | 150 mL in 1 BOTTLE | 150 ml | Historical | ||||
| 73516-450-01 | 73516045001 | 1 KIT in 1 CARTON (73516-450-01) * 1 BOTTLE in 1 CARTON (70512-038-05) > 150 mL in 1 BOTTLE | 1 kit | 2022-02-01 | 0000-00-00 | No | No | Current |