buprenorphine transdermal system
- Product NDC
- 58064-408
- 11-digit product format
- 580640408
- Labeler code
- 58064
- Product ID
- 58064-408_45afa585-2243-cf7b-e063-6394a90a74e1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- LTS Therapy Systems, LLC
- Application
- ANDA207490
- Marketing category
- ANDA
- Marketing start
- 2022-05-17
- Substance
- BUPRENORPHINE
- Active strength
- 20 ug/h
- Pharmacologic classes
- Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- buprenorphine transdermal system
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPRENORPHINE | 20 ug/h |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58064-408-04 | 58064040804 | 4 POUCH in 1 CARTON (58064-408-04) / 1 PATCH in 1 POUCH (58064-408-11) / 168 h in 1 PATCH | 4 pouch | 2022-08-29 | 0000-00-00 | No | No | Current |