Diclofenac Sodium Topical Solution
- Product NDC
- 50742-308
- 11-digit product format
- 507420308
- Labeler code
- 50742
- Product ID
- 50742-308_ba0455ca-e0e9-4ceb-a24e-0b21dfdda39a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Ingenus Pharmaceuticals, LLC
- Application
- ANDA206715
- Marketing category
- ANDA
- Marketing start
- 2017-11-01
- Marketing end
- 2021-02-28
- Substance
- DICLOFENAC SODIUM
- Active strength
- 16 mg/mL
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50742-308-05 | ML - Milliliter | 50742-308 | b4beb9fc-8d7a-435c-bfae-87989d9cce5f | 1 | 2017-12-14 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 857700 | diclofenac sodium 1.5 % Topical Solution | PSN | 9af13122-73b2-95de-e053-2995a90a0505 | 1 |
| 857700 | diclofenac sodium 15 MG/ML Topical Solution | SCD | 9af13122-73b2-95de-e053-2995a90a0505 | 1 |
| 857700 | diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution | SY | 9af13122-73b2-95de-e053-2995a90a0505 | 1 |
| 857700 | diclofenac sodium 16.05 MG per 1 ML Topical Solution | SY | 9af13122-73b2-95de-e053-2995a90a0505 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50742-308-05 | 50742030805 | 1 BOTTLE, DROPPER in 1 CARTON (50742-308-05) > 150 mL in 1 BOTTLE, DROPPER | 2017-11-01 | 2021-02-28 | No | No | Current |