Voltaren
- Product NDC
- 68387-456
- 11-digit product format
- 683870456
- Labeler code
- 68387
- Product ID
- 68387-456_9c160477-60c6-4f71-9269-48432b6799f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diclofenac sodium
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Keltman Pharmaceuticals Inc.
- Application
- NDA022122
- Marketing category
- NDA
- Marketing start
- 2011-01-27
- 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
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|---|---|---|---|---|
| 68387-456-01 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-c27e-8e05-e053-dbdaa90a074a | These highlights do not include all the information needed to use Voltaren® Gel safely and effectively. See full prescribing information for Voltaren® Gel. Initial U.S. Approval: 1988 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68387-456-01 | Voltaren | 100 g in 1 TUBE | GEL | 100 | 1 | |
| 68387-456-01 | Voltaren | 1 in 1 CARTON | GEL | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68387-456-01 | GM - Gram | 68387-456 | af632620-0ae6-412b-90b3-45d3bc2cc926 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 855633 | diclofenac sodium 1 % Topical Gel | PSN | 26b2d99e-d471-4758-8aa0-a26ef464eb35 | 1 |
| 855635 | Voltaren 1 % Topical Gel | PSN | 26b2d99e-d471-4758-8aa0-a26ef464eb35 | 1 |
| 855635 | diclofenac sodium 0.01 MG/MG Topical Gel [Voltaren] | SBD | 26b2d99e-d471-4758-8aa0-a26ef464eb35 | 1 |
| 855633 | diclofenac sodium 0.01 MG/MG Topical Gel | SCD | 26b2d99e-d471-4758-8aa0-a26ef464eb35 | 1 |
| 855633 | diclofenac sodium 1 % Topical Gel | SY | 26b2d99e-d471-4758-8aa0-a26ef464eb35 | 1 |
| 855635 | Voltaren 0.01 MG/MG Topical Gel | SY | 26b2d99e-d471-4758-8aa0-a26ef464eb35 | 1 |
| 855635 | Voltaren 1 % Topical Gel | SY | 26b2d99e-d471-4758-8aa0-a26ef464eb35 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 68387-456-01 | 68387045601 | 100 g in 1 TUBE | 100 g | Historical |