Rivastigmine Transdermal System
- Product NDC
- 51991-899
- 11-digit product format
- 519910899
- Labeler code
- 51991
- Product ID
- 51991-899_6c0c606b-108e-4837-8533-f485f9e4ee4b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rivastigmine
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- Breckenridge Pharmaceutical, Inc.
- Application
- ANDA209063
- Marketing category
- ANDA
- Marketing start
- 2019-12-19
- Substance
- RIVASTIGMINE
- Active strength
- 13.3 mg/24h
- Pharmacologic classes
- Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rivastigmine Transdermal System
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| RIVASTIGMINE | 13.3 mg/24h |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | PKI06M3IW0 |
| Rxcui | 725021, 725023, 1308569 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51991-899-30 | Rivastigmine Transdermal System | 30 in 1 CARTON | PATCH, EXTENDED RELEASE | 30 | 7 | |
| 51991-899-99 | Rivastigmine Transdermal System | 24 h in 1 PATCH | PATCH, EXTENDED RELEASE | 24 | 7 | |
| 51991-899-99 | Rivastigmine Transdermal System | 1 in 1 POUCH | PATCH, EXTENDED RELEASE | 1 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51991-899-30 | EA - Each | 51991-899 | 6574ef94-12dd-47ba-a67a-b1e411fc528f | 1 | 2020-02-13 |
| 51991-899-99 | EA - Each | 51991-899 | bf6e8d11-85e2-4dc6-a50d-7e5050b0676b | 1 | 2020-02-13 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1308569 | rivastigmine 13.3 MG/Day 24HR Transdermal System | PSN | 5cd5c434-ffd0-4aed-9eba-145c86b115bb | 111 |
| 1308569 | 24 HR rivastigmine 0.554 MG/HR Transdermal System | SCD | 5cd5c434-ffd0-4aed-9eba-145c86b115bb | 111 |
| 1308569 | rivastigmine 13.3 MG/Day 24HR Transdermal Patch | SY | 5cd5c434-ffd0-4aed-9eba-145c86b115bb | 111 |
| 1308569 | rivastigmine 13.3 MG/Day 24HR Transdermal System | SY | 5cd5c434-ffd0-4aed-9eba-145c86b115bb | 111 |
| 1308569 | rivastigmine 13.3 MG/Day 24HR Transdermal System | PSN | 6cc286d9-c5d4-4505-83bb-9015e3077851 | 106 |
| 1308569 | 24 HR rivastigmine 0.554 MG/HR Transdermal System | SCD | 6cc286d9-c5d4-4505-83bb-9015e3077851 | 106 |
| 1308569 | rivastigmine 13.3 MG/Day 24HR Transdermal Patch | SY | 6cc286d9-c5d4-4505-83bb-9015e3077851 | 106 |
| 1308569 | rivastigmine 13.3 MG/Day 24HR Transdermal System | SY | 6cc286d9-c5d4-4505-83bb-9015e3077851 | 106 |
| 1308569 | rivastigmine 13.3 MG/Day 24HR Transdermal System | PSN | 8d8823c0-9339-4ec8-8a19-d13974b6614b | 102 |
| 1308569 | 24 HR rivastigmine 0.554 MG/HR Transdermal System | SCD | 8d8823c0-9339-4ec8-8a19-d13974b6614b | 102 |
| 1308569 | rivastigmine 13.3 MG/Day 24HR Transdermal Patch | SY | 8d8823c0-9339-4ec8-8a19-d13974b6614b | 102 |
| 1308569 | rivastigmine 13.3 MG/Day 24HR Transdermal System | SY | 8d8823c0-9339-4ec8-8a19-d13974b6614b | 102 |
| 1308569 | rivastigmine 13.3 MG/Day 24HR Transdermal System | PSN | b201fe68-b5e5-4a6f-8cf1-069543f03e76 | 7 |
| 725021 | rivastigmine 4.6 MG/Day 24HR Transdermal System | PSN | b201fe68-b5e5-4a6f-8cf1-069543f03e76 | 7 |
| 725023 | rivastigmine 9.5 MG/Day 24HR Transdermal System | PSN | b201fe68-b5e5-4a6f-8cf1-069543f03e76 | 7 |
| 725021 | 24 HR rivastigmine 0.192 MG/HR Transdermal System | SCD | b201fe68-b5e5-4a6f-8cf1-069543f03e76 | 7 |
| 725023 | 24 HR rivastigmine 0.396 MG/HR Transdermal System | SCD | b201fe68-b5e5-4a6f-8cf1-069543f03e76 | 7 |
| 1308569 | 24 HR rivastigmine 0.554 MG/HR Transdermal System | SCD | b201fe68-b5e5-4a6f-8cf1-069543f03e76 | 7 |
| 725021 | rivastigmine 0.192 MG/HR 24 HR Transdermal Patch | SY | b201fe68-b5e5-4a6f-8cf1-069543f03e76 | 7 |
| 725023 | rivastigmine 0.396 MG/HR 24 HR Transdermal Patch | SY | b201fe68-b5e5-4a6f-8cf1-069543f03e76 | 7 |
| 1308569 | rivastigmine 13.3 MG/Day 24HR Transdermal Patch | SY | b201fe68-b5e5-4a6f-8cf1-069543f03e76 | 7 |
| 1308569 | rivastigmine 13.3 MG/Day 24HR Transdermal System | SY | b201fe68-b5e5-4a6f-8cf1-069543f03e76 | 7 |
| 725021 | rivastigmine 4.6 MG/Day 24 HR Transdermal Patch | SY | b201fe68-b5e5-4a6f-8cf1-069543f03e76 | 7 |
| 725021 | rivastigmine 4.6 MG/Day 24HR Transdermal System | SY | b201fe68-b5e5-4a6f-8cf1-069543f03e76 | 7 |
| 725023 | rivastigmine 9.5 MG/Day 24 HR Transdermal Patch | SY | b201fe68-b5e5-4a6f-8cf1-069543f03e76 | 7 |
| 725023 | rivastigmine 9.5 MG/Day 24HR Transdermal System | SY | b201fe68-b5e5-4a6f-8cf1-069543f03e76 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51991-899-30 | 51991089930 | 30 POUCH in 1 CARTON (51991-899-30) / 1 PATCH in 1 POUCH (51991-899-99) / 24 h in 1 PATCH | 30 pouch | 2019-12-19 | 0000-00-00 | No | No | Current |
| 51991-899-99 | 51991089999 | 24 h in 1 PATCH | 24 h | Historical |