Rivastigmine
- Product NDC
- 51956-0002
- 11-digit product format
- 519560002
- Labeler code
- 51956
- Product ID
- 51956-0002_8ce6f8ae-c5f5-4731-8efb-9a8c3d52942f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rivastigmine
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA206318
- Marketing category
- ANDA
- Marketing start
- 2019-03-06
- Marketing end
- 0000-00-00
- Substance
- RIVASTIGMINE
- Active strength
- 10 mg/24h
- Pharmacologic classes
- Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
- 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 |
|---|---|---|---|
| f5a24cc0-a293-4838-b663-7e454a66c2c3 | Product name | 5 | 20200513 |
| 64bcf1db-afe4-78b0-8e9c-f7cb25e1b791 | Product name | 6 | 20171121 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51956-0002-7 | 2026-01-29 | C162847 | 48780-1 | 49896155-c1d0-586f-e063-e6dba90add90 | These highlights do not include all the information needed to use RIVASTIGMINE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for RIVASTIGMINE TRANSDERMAL SYSTEM. Rivastigmine Transdermal System Initial U.S. Approval: 2000 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51956-0002-1 | Rivastigmine | 24 h in 1 POUCH | PATCH, EXTENDED RELEASE | 24 | 3 | |
| 51956-0002-7 | Rivastigmine | 30 in 1 CARTON | PATCH, EXTENDED RELEASE | 30 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51956-0002 | RIVASTIGMINE PATCH, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED] | 3 | Legacy NDC, 2 package rows | 20221007_7d8414f5-b51f-4ccb-b7a1-83b9ede5b266.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1308569 | rivastigmine 13.3 MG/Day 24HR Transdermal System | PSN | 7d8414f5-b51f-4ccb-b7a1-83b9ede5b266 | 3 |
| 725021 | rivastigmine 4.6 MG/Day 24HR Transdermal System | PSN | 7d8414f5-b51f-4ccb-b7a1-83b9ede5b266 | 3 |
| 725023 | rivastigmine 9.5 MG/Day 24HR Transdermal System | PSN | 7d8414f5-b51f-4ccb-b7a1-83b9ede5b266 | 3 |
| 725021 | 24 HR rivastigmine 0.192 MG/HR Transdermal System | SCD | 7d8414f5-b51f-4ccb-b7a1-83b9ede5b266 | 3 |
| 725023 | 24 HR rivastigmine 0.396 MG/HR Transdermal System | SCD | 7d8414f5-b51f-4ccb-b7a1-83b9ede5b266 | 3 |
| 1308569 | 24 HR rivastigmine 0.554 MG/HR Transdermal System | SCD | 7d8414f5-b51f-4ccb-b7a1-83b9ede5b266 | 3 |
| 725021 | rivastigmine 0.192 MG/HR 24 HR Transdermal Patch | SY | 7d8414f5-b51f-4ccb-b7a1-83b9ede5b266 | 3 |
| 725023 | rivastigmine 0.396 MG/HR 24 HR Transdermal Patch | SY | 7d8414f5-b51f-4ccb-b7a1-83b9ede5b266 | 3 |
| 1308569 | rivastigmine 13.3 MG/Day 24HR Transdermal Patch | SY | 7d8414f5-b51f-4ccb-b7a1-83b9ede5b266 | 3 |
| 1308569 | rivastigmine 13.3 MG/Day 24HR Transdermal System | SY | 7d8414f5-b51f-4ccb-b7a1-83b9ede5b266 | 3 |
| 725021 | rivastigmine 4.6 MG/Day 24 HR Transdermal Patch | SY | 7d8414f5-b51f-4ccb-b7a1-83b9ede5b266 | 3 |
| 725021 | rivastigmine 4.6 MG/Day 24HR Transdermal System | SY | 7d8414f5-b51f-4ccb-b7a1-83b9ede5b266 | 3 |
| 725023 | rivastigmine 9.5 MG/Day 24 HR Transdermal Patch | SY | 7d8414f5-b51f-4ccb-b7a1-83b9ede5b266 | 3 |
| 725023 | rivastigmine 9.5 MG/Day 24HR Transdermal System | SY | 7d8414f5-b51f-4ccb-b7a1-83b9ede5b266 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51956-0002-1 | 51956000201 | 24 h in 1 POUCH | 24 h | Historical | ||||
| 51956-0002-7 | 51956000207 | 30 POUCH in 1 CARTON (51956-0002-7) > 24 h in 1 POUCH (51956-0002-1) | 30 pouch | 2019-03-06 | 0000-00-00 | No | No | Current |