Buprenorphine
- Product NDC
- 3215-1521
- 11-digit product format
- 032151521
- Labeler code
- 3215
- Product ID
- 3215-1521_509150ac-3394-c793-e063-6294a90ab2ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- Aveva Drug Delivery Systems Inc.
- Application
- ANDA210272
- Marketing category
- ANDA
- Marketing start
- 2023-11-01
- Substance
- BUPRENORPHINE
- Active strength
- 5 ug/h
- Pharmacologic classes
- Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Buprenorphine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUPRENORPHINE | 5 ug/h |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 40D3SCR4GZ |
| Rxcui | 904870, 904876, 904880, 1432969, 1542997 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 68654759-f50b-79ef-24c5-544d94fe7d87 | Product name | 3 | 20251114 |
| 08a295bb-88df-4ab0-a120-a75a789a74f1 | Product name | 1 | 20231013 |
| ab841ac7-728a-4fc9-be0a-35b96cecbf39 | Product name | 4 | 20230306 |
| 100316cc-94a9-474e-97ad-9b5c6ddec605 | Product name | 5 | 20230125 |
| 539bc5d3-546b-4af6-9c31-058ce6c459d3 | Product name | 2 | 20220210 |
| b871fccd-1de6-4c7f-b9e5-045304641ee6 | Product name | 8 | 20220118 |
| 31e16ab2-c562-4617-a3e8-ed285320e16e | Product name | 1 | 20180201 |
| 4c23a34c-e8fc-424c-8fa0-ee064ba6eaef | Product name | 1 | 20170706 |
| a5920611-4285-f024-69b9-39ff338b81ea | Product name | 5 | 20170609 |
| 3df867ed-9d48-45cf-bded-1394beaea0b1 | Product name | 3 | 20161206 |
| 973da5bf-b1f9-4de0-81ee-7ca066c98ca4 | Product name | 1 | 20160712 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 3215-1521-04 | Buprenorphine | 1 in 1 POUCH | PATCH, EXTENDED RELEASE | 1 | 3 | |
| 3215-1521-04 | Buprenorphine | 4 in 1 CARTON | PATCH, EXTENDED RELEASE | 4 | 3 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 904870 | buprenorphine 10 MCG/HR 7 Day Transdermal System | PSN | 1aae9b13-7431-42ef-8558-14a2325820e6 | 3 |
| 1432969 | buprenorphine 15 MCG/HR 7 Day Transdermal System | PSN | 1aae9b13-7431-42ef-8558-14a2325820e6 | 3 |
| 904876 | buprenorphine 20 MCG/HR 7 Day Transdermal System | PSN | 1aae9b13-7431-42ef-8558-14a2325820e6 | 3 |
| 904880 | buprenorphine 5 MCG/HR 7 Day Transdermal System | PSN | 1aae9b13-7431-42ef-8558-14a2325820e6 | 3 |
| 1542997 | buprenorphine 7.5 MCG/HR 7 Day Transdermal System | PSN | 1aae9b13-7431-42ef-8558-14a2325820e6 | 3 |
| 904880 | 168 HR buprenorphine 0.005 MG/HR Transdermal System | SCD | 1aae9b13-7431-42ef-8558-14a2325820e6 | 3 |
| 1542997 | 168 HR buprenorphine 0.0075 MG/HR Transdermal System | SCD | 1aae9b13-7431-42ef-8558-14a2325820e6 | 3 |
| 904870 | 168 HR buprenorphine 0.01 MG/HR Transdermal System | SCD | 1aae9b13-7431-42ef-8558-14a2325820e6 | 3 |
| 1432969 | 168 HR buprenorphine 0.015 MG/HR Transdermal System | SCD | 1aae9b13-7431-42ef-8558-14a2325820e6 | 3 |
| 904876 | 168 HR buprenorphine 0.02 MG/HR Transdermal System | SCD | 1aae9b13-7431-42ef-8558-14a2325820e6 | 3 |
| 904870 | buprenorphine 10 MCG/HR 7 Day Transdermal System | SY | 1aae9b13-7431-42ef-8558-14a2325820e6 | 3 |
| 904870 | buprenorphine 10 MCG/HR Weekly Transdermal Patch | SY | 1aae9b13-7431-42ef-8558-14a2325820e6 | 3 |
| 1432969 | buprenorphine 15 MCG/HR 7 Day Transdermal System | SY | 1aae9b13-7431-42ef-8558-14a2325820e6 | 3 |
| 1432969 | buprenorphine 15 MCG/HR Weekly Transdermal Patch | SY | 1aae9b13-7431-42ef-8558-14a2325820e6 | 3 |
| 904876 | buprenorphine 20 MCG/HR 7 Day Transdermal System | SY | 1aae9b13-7431-42ef-8558-14a2325820e6 | 3 |
| 904876 | buprenorphine 20 MCG/HR Weekly Transdermal Patch | SY | 1aae9b13-7431-42ef-8558-14a2325820e6 | 3 |
| 904880 | buprenorphine 5 MCG/HR 7 Day Transdermal System | SY | 1aae9b13-7431-42ef-8558-14a2325820e6 | 3 |
| 904880 | buprenorphine 5 MCG/HR Weekly Transdermal Patch | SY | 1aae9b13-7431-42ef-8558-14a2325820e6 | 3 |
| 1542997 | buprenorphine 7.5 MCG/HR 7 Day Transdermal Patch | SY | 1aae9b13-7431-42ef-8558-14a2325820e6 | 3 |
| 1542997 | buprenorphine 7.5 MCG/HR 7 Day Transdermal System | SY | 1aae9b13-7431-42ef-8558-14a2325820e6 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 3215-1521-04 | 03215152104 | 4 POUCH in 1 CARTON (3215-1521-04) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH | 4 pouch | 2023-11-01 | No | No | Current |