buprenorphine transdermal system
- Product NDC
- 47781-406
- 11-digit product format
- 477810406
- Labeler code
- 47781
- Product ID
- 47781-406_7f83c8aa-7590-e2fe-4998-55323eadd112
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- Alvogen Inc.
- Application
- ANDA207490
- Marketing category
- ANDA
- Marketing start
- 2022-05-17
- Marketing end
- 2027-01-31
- Substance
- BUPRENORPHINE
- Active strength
- 5 ug/h
- Pharmacologic classes
- Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- buprenorphine transdermal system
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUPRENORPHINE | 5 ug/h |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 40D3SCR4GZ |
| Rxcui | 904870, 904876, 904880, 1432969 |
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 47781-406-04 | 2024-01-30 | C162847 | 48780-1 | 1030e365-39fc-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use BUPRENORPHINE TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for BUPRENORPHINE TRANSDERMAL SYSTEM. BUPRENORPHINE transdermal system, CIII Initial U.S. Approval: 1981 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 47781-406-04 | buprenorphine transdermal system | 4 in 1 CARTON | PATCH, EXTENDED RELEASE | 4 | 4 | |
| 47781-406-11 | buprenorphine transdermal system | 1 in 1 POUCH | PATCH, EXTENDED RELEASE | 1 | 4 | |
| 47781-406-11 | buprenorphine transdermal system | 168 h in 1 PATCH | PATCH, EXTENDED RELEASE | 168 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 47781-406-04 | EA - Each | 47781-406 | 6581c352-328b-4ec4-b23c-e10cbe93c676 | 1 | 2022-11-07 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 904870 | buprenorphine 10 MCG/HR 7 Day Transdermal System | PSN | 315284b8-32ab-d34a-ea02-f501c6131bcc | 4 |
| 1432969 | buprenorphine 15 MCG/HR 7 Day Transdermal System | PSN | 315284b8-32ab-d34a-ea02-f501c6131bcc | 4 |
| 904876 | buprenorphine 20 MCG/HR 7 Day Transdermal System | PSN | 315284b8-32ab-d34a-ea02-f501c6131bcc | 4 |
| 904880 | buprenorphine 5 MCG/HR 7 Day Transdermal System | PSN | 315284b8-32ab-d34a-ea02-f501c6131bcc | 4 |
| 904880 | 168 HR buprenorphine 0.005 MG/HR Transdermal System | SCD | 315284b8-32ab-d34a-ea02-f501c6131bcc | 4 |
| 904870 | 168 HR buprenorphine 0.01 MG/HR Transdermal System | SCD | 315284b8-32ab-d34a-ea02-f501c6131bcc | 4 |
| 1432969 | 168 HR buprenorphine 0.015 MG/HR Transdermal System | SCD | 315284b8-32ab-d34a-ea02-f501c6131bcc | 4 |
| 904876 | 168 HR buprenorphine 0.02 MG/HR Transdermal System | SCD | 315284b8-32ab-d34a-ea02-f501c6131bcc | 4 |
| 904870 | buprenorphine 10 MCG/HR 7 Day Transdermal System | SY | 315284b8-32ab-d34a-ea02-f501c6131bcc | 4 |
| 904870 | buprenorphine 10 MCG/HR Weekly Transdermal Patch | SY | 315284b8-32ab-d34a-ea02-f501c6131bcc | 4 |
| 1432969 | buprenorphine 15 MCG/HR 7 Day Transdermal System | SY | 315284b8-32ab-d34a-ea02-f501c6131bcc | 4 |
| 1432969 | buprenorphine 15 MCG/HR Weekly Transdermal Patch | SY | 315284b8-32ab-d34a-ea02-f501c6131bcc | 4 |
| 904876 | buprenorphine 20 MCG/HR 7 Day Transdermal System | SY | 315284b8-32ab-d34a-ea02-f501c6131bcc | 4 |
| 904876 | buprenorphine 20 MCG/HR Weekly Transdermal Patch | SY | 315284b8-32ab-d34a-ea02-f501c6131bcc | 4 |
| 904880 | buprenorphine 5 MCG/HR 7 Day Transdermal System | SY | 315284b8-32ab-d34a-ea02-f501c6131bcc | 4 |
| 904880 | buprenorphine 5 MCG/HR Weekly Transdermal Patch | SY | 315284b8-32ab-d34a-ea02-f501c6131bcc | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 47781-406-04 | 47781040604 | 4 POUCH in 1 CARTON (47781-406-04) / 1 PATCH in 1 POUCH (47781-406-11) / 168 h in 1 PATCH | 4 pouch | 2022-08-29 | 2027-01-31 | No | No | Current |
| 47781-406-11 | 47781040611 | 1 in 1 POUCH | Historical |