Diclofenac Sodium
- Product NDC
- 50090-4016
- 11-digit product format
- 500904016
- Labeler code
- 50090
- Product ID
- 50090-4016_fc0e2c12-0fb8-4da0-9f9f-c42ff8581294
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA202027
- Marketing category
- ANDA
- Marketing start
- 2014-05-28
- Marketing end
- 0000-00-00
- 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
- 2020-12-31
- 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 |
|---|---|---|---|---|---|
| 50090-4016-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-10de-0266-e053-dadaa90a7c1a | 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 1.5% w/w, for topical use Initial U.S. Approval: 1988 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-4016-0 | Diclofenac Sodium | 1 in 1 CARTON | SOLUTION | 1 | 1 | |
| 50090-4016-0 | Diclofenac Sodium | 150 mL in 1 BOTTLE | SOLUTION | 150 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-4016 | DICLOFENAC SODIUM SOLUTION [A-S MEDICATION SOLUTIONS] | 1 | Legacy NDC, 2 package rows | 20190123_2bf4c5e6-8486-473f-9692-34394079ec2c.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 857700 | diclofenac sodium 1.5 % Topical Solution | PSN | 2bf4c5e6-8486-473f-9692-34394079ec2c | 1 |
| 857700 | diclofenac sodium 15 MG/ML Topical Solution | SCD | 2bf4c5e6-8486-473f-9692-34394079ec2c | 1 |
| 857700 | diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution | SY | 2bf4c5e6-8486-473f-9692-34394079ec2c | 1 |
| 857700 | diclofenac sodium 16.05 MG per 1 ML Topical Solution | SY | 2bf4c5e6-8486-473f-9692-34394079ec2c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-4016-0 | 50090401600 | 1 BOTTLE in 1 CARTON (50090-4016-0) > 150 mL in 1 BOTTLE | 1 bottle | 2019-01-03 | 0000-00-00 | No | No | Current |