Diclofenac Sodium
- Product NDC
- 50090-5075
- 11-digit product format
- 500905075
- Labeler code
- 50090
- Product ID
- 50090-5075_af1bc9b2-5cd2-4e86-86a7-52230409c64b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA209903
- Marketing category
- ANDA
- Marketing start
- 2019-10-18
- Marketing end
- 0000-00-00
- Substance
- DICLOFENAC SODIUM
- Active strength
- 10 mg/g
- 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
- 2021-12-31
- 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 |
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 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 |
|---|---|---|---|---|---|
| 50090-5075-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-9ebf-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL GEL safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL GEL. DICLOFENAC SODIUM topical gel, 1%, for topical use only Initial U.S. Approval: 1988 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-5075-0 | Diclofenac Sodium | 1 in 1 CARTON | GEL | 1 | 1 | |
| 50090-5075-0 | Diclofenac Sodium | 100 g in 1 TUBE | GEL | 100 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-5075 | DICLOFENAC SODIUM GEL [A-S MEDICATION SOLUTIONS] | 1 | Legacy NDC, 2 package rows | 20200808_249f4547-deb1-47bc-8864-bae11124e4d0.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 855633 | diclofenac sodium 1 % Topical Gel | PSN | 249f4547-deb1-47bc-8864-bae11124e4d0 | 1 |
| 855633 | diclofenac sodium 0.01 MG/MG Topical Gel | SCD | 249f4547-deb1-47bc-8864-bae11124e4d0 | 1 |
| 855633 | diclofenac sodium 1 % Topical Gel | SY | 249f4547-deb1-47bc-8864-bae11124e4d0 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-5075-0 | 50090507500 | 1 TUBE in 1 CARTON (50090-5075-0) > 100 g in 1 TUBE | 1 tube | 2020-06-16 | 0000-00-00 | No | No | Current |