Diclofenac Sodium
- Product NDC
- 50436-6925
- 11-digit product format
- 504366925
- Labeler code
- 50436
- Product ID
- 50436-6925_dee8075a-2d03-4359-bcc5-d130ef37b65b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA075910
- Marketing category
- ANDA
- Marketing start
- 2002-01-09
- Marketing end
- 0000-00-00
- Substance
- DICLOFENAC SODIUM
- Active strength
- 100 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
- 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 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 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 |
|---|---|---|---|---|---|
| 50436-6925-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2bf2-a910-e053-dadaa90a0b85 | Diclofenac Sodium Extended-Release Tablets, USP |
| 50436-6925-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2bf2-a910-e053-dadaa90a0b85 | Diclofenac Sodium Extended-Release Tablets, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-6925-1 | Diclofenac Sodium | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | 4 | |
| 50436-6925-2 | Diclofenac Sodium | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-6925-1 | EA - Each | 50436-6925 | fdffab2d-4615-45cd-ab38-d8ede8f9137f | 1 | 2013-04-01 |
| 50436-6925-2 | EA - Each | 50436-6925 | ec27aaed-9361-43cc-8320-804f5bc9f3ff | 1 | 2013-04-01 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-6925 | DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [UNIT DOSE SERVICES] | 4 | Legacy NDC, 2 package rows | 20160423_164fc722-1b31-42fc-b0b5-5b7398983151.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 855657 | diclofenac sodium 100 MG 24HR Extended Release Oral Tablet | PSN | 164fc722-1b31-42fc-b0b5-5b7398983151 | 4 |
| 855657 | 24 HR diclofenac sodium 100 MG Extended Release Oral Tablet | SCD | 164fc722-1b31-42fc-b0b5-5b7398983151 | 4 |
| 855657 | diclofenac sodium 100 MG 24 HR Extended Release Oral Tablet | SY | 164fc722-1b31-42fc-b0b5-5b7398983151 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-6925-1 | 50436692501 | 30 in 1 BOTTLE | Historical |
| 50436-6925-2 | 50436692502 | 60 in 1 BOTTLE | Historical |