Diclofenac Potassium
- Product NDC
- 53002-1176
- 11-digit product format
- 530021176
- Labeler code
- 53002
- Product ID
- 53002-1176_30dc3f72-2350-430c-be55-a3132e6936a3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA075219
- Marketing category
- ANDA
- Marketing start
- 1998-08-11
- Marketing end
- 0000-00-00
- Substance
- DICLOFENAC POTASSIUM
- Active strength
- 50 mg/1
- 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 |
| 855d63c3-b090-4636-8fc7-6d39ad23c44f | Product name | 1 | 20230829 |
| bb58f410-04be-65dd-9211-e89ead899698 | Product name | 6 | 20230323 |
| 351abe41-466c-4dd8-840a-0fdb68318bd5 | Product name | 1 | 20230316 |
| 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 |
|---|---|---|---|---|---|
| 53002-1176-3 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-f99a-f424-e053-dadaa90a57ce | Diclofenac Potassium Tablets, USP 50 mg Rx only |
| 53002-1176-3 | 2023-06-08 | C162847 | 48780-1 | 9d75b9d0-f99a-f424-e053-dadaa90a57ce | Diclofenac Potassium Tablets, USP 50 mg Rx only |
| 53002-1176-3 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-f99a-f424-e053-dadaa90a57ce | Diclofenac Potassium Tablets, USP 50 mg Rx only |
| 53002-1176-3 | 2020-12-29 | C162847 | 48780-1 | 9d75b9d0-f99a-f424-e053-dadaa90a57ce | Diclofenac Potassium Tablets, USP 50 mg Rx only |
| 53002-1176-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f99a-f424-e053-dadaa90a57ce | Diclofenac Potassium Tablets, USP 50 mg Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-1176-3 | Diclofenac Potassium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-1176 | DICLOFENAC POTASSIUM TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20230609_90c6d882-aea2-439a-a3c1-53255d12ae94.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 855942 | diclofenac potassium 50 MG Oral Tablet | PSN | 90c6d882-aea2-439a-a3c1-53255d12ae94 | 5 |
| 855942 | diclofenac potassium 50 MG Oral Tablet | SCD | 90c6d882-aea2-439a-a3c1-53255d12ae94 | 5 |
| 855942 | Diclofenac K+ 50 MG Oral Tablet | SY | 90c6d882-aea2-439a-a3c1-53255d12ae94 | 5 |
| 855942 | Diclofenac Pot 50 MG Oral Tablet | SY | 90c6d882-aea2-439a-a3c1-53255d12ae94 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 53002-1176-3 | 53002117603 | 30 TABLET, FILM COATED in 1 BOTTLE (53002-1176-3) | 2018-10-01 | 0000-00-00 | No | No | Current |