Diclofenac Sodium and Misoprostol
- Product NDC
- 10544-955
- 11-digit product format
- 105440955
- Labeler code
- 10544
- Product ID
- 10544-955_3282624b-6a8a-16b4-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium and Misoprostol
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA200540
- Marketing category
- ANDA
- Marketing start
- 2014-07-15
- Marketing end
- 0000-00-00
- Substance
- DICLOFENAC SODIUM; MISOPROSTOL
- Active strength
- 75 mg/1; mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]
- 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 |
| 73109aa8-3e7c-b7a0-fb29-6f84db91e7d9 | Product name | 3 | 20231221 |
| 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 |
|---|---|---|---|---|---|
| 10544-955-14 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-15f4-f424-e053-dadaa90a57ce | Diclofenac sodium and misoprostol delayed-release tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10544-955-14 | Diclofenac Sodium and MisoprostolDelayed-Release | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 10544-955 | DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | Legacy NDC, 1 package rows | 20160510_31dd8572-989c-1416-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1359105 | diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral Tablet | PSN | 31dd8572-989c-1416-e054-00144ff8d46c | 2 |
| 1359105 | diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral Tablet | SCD | 31dd8572-989c-1416-e054-00144ff8d46c | 2 |
| 1359105 | diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral Tablet | SY | 31dd8572-989c-1416-e054-00144ff8d46c | 2 |
| 1359105 | diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral Tablet | SY | 31dd8572-989c-1416-e054-00144ff8d46c | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 10544-955-14 | 10544095514 | 14 in 1 BOTTLE | Historical |