Diclofenac Sodium
- Product NDC
- 76282-663
- 11-digit product format
- 762820663
- Labeler code
- 76282
- Product ID
- 76282-663_dfb07ce9-301f-49b9-85e0-f3b42a50cbf6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- EXELAN PHARMACEUTICALS INC.
- 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
- 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 |
| 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 |
|---|---|---|---|---|---|
| 76282-663-39 | 2023-08-22 | C162847 | 48780-1 | d6a99b39-ecaa-a426-e053-dadaa90af4c2 | 4d0f7c39-f0bd-40bb-9a8f-c864ba0ea4bf |
| 76282-663-39 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ecaa-a426-e053-dadaa90af4c2 | 4d0f7c39-f0bd-40bb-9a8f-c864ba0ea4bf |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 76282-663-39 | GM - Gram | 76282-663 | b5f05002-7c69-4559-bc5e-a72e405fd0df | 1 | 2019-12-10 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 855633 | diclofenac sodium 1 % Topical Gel | PSN | 1b8ffc26-cef5-42a5-81a6-2317ad0b9f9e | 1 |
| 855633 | diclofenac sodium 1 % Topical Gel | PSN | 249f4547-deb1-47bc-8864-bae11124e4d0 | 1 |
| 855633 | diclofenac sodium 0.01 MG/MG Topical Gel | SCD | 1b8ffc26-cef5-42a5-81a6-2317ad0b9f9e | 1 |
| 855633 | diclofenac sodium 0.01 MG/MG Topical Gel | SCD | 249f4547-deb1-47bc-8864-bae11124e4d0 | 1 |
| 855633 | diclofenac sodium 1 % Topical Gel | SY | 1b8ffc26-cef5-42a5-81a6-2317ad0b9f9e | 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 |
|---|---|---|---|---|---|---|---|---|
| 76282-663-39 | 76282066339 | 1 TUBE in 1 CARTON (76282-663-39) > 100 g in 1 TUBE | 1 tube | 2019-10-18 | 0000-00-00 | No | No | Current |