Diclofenac Sodium
- Product NDC
- 50436-2201
- 11-digit product format
- 504362201
- Labeler code
- 50436
- Product ID
- 50436-2201_baa52ef7-0383-4d8b-93a5-5d1fbf95b434
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA077863
- Marketing category
- ANDA
- Marketing start
- 2008-08-19
- Marketing end
- 0000-00-00
- Substance
- DICLOFENAC SODIUM
- Active strength
- 75 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|---|---|---|---|---|
| 50436-2201-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3d15-111a-e063-dadaa90a10e2 | Diclofenac Sodium Delayed-release Tablets, USP 25 mg, 50 mg and 75 mg |
| 50436-2201-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3d15-111a-e063-dadaa90a10e2 | Diclofenac Sodium Delayed-release Tablets, USP 25 mg, 50 mg and 75 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-2201-1 | Diclofenac Sodium | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | 2 | |
| 50436-2201-2 | Diclofenac Sodium | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-2201-1 | EA - Each | 50436-2201 | c4dae64f-402c-456a-be2a-fb408d97a670 | 1 | 2022-07-06 |
| 50436-2201-2 | EA - Each | 50436-2201 | 3efb9daa-d44f-4a1a-9b10-99c534a28020 | 1 | 2022-07-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-2201 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES] | 2 | Legacy NDC, 2 package rows | 20220517_2c67e16a-9772-491e-a00f-8633451ca1bf.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 2c67e16a-9772-491e-a00f-8633451ca1bf | 2 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 2c67e16a-9772-491e-a00f-8633451ca1bf | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50436-2201-1 | 50436220101 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50436-2201-1) | 2021-12-14 | 0000-00-00 | No | No | Current |
| 50436-2201-2 | 50436220102 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (50436-2201-2) | 2021-12-14 | 0000-00-00 | No | No | Current |