Buprenorphine Hydrochloride Sublingual
- Product NDC
- 0378-0923
- 11-digit product format
- 003780923
- Labeler code
- 0378
- Product ID
- 0378-0923_140de61a-37dc-465e-a4c6-35b605b918a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine hydrochloride sublingual
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA201066
- Marketing category
- ANDA
- Marketing start
- 2015-03-06
- Marketing end
- 2019-10-31
- Substance
- BUPRENORPHINE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-0923-93 | EA - Each | 0378-0923 | 38463cf4-e7ba-4582-b78e-15d5cfb9b5b0 | 1 | 2015-04-03 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 351264 | buprenorphine HCl 2 MG Sublingual Tablet | PSN | 593c2a50-de4f-6bf8-e053-2a91aa0ae306 | 1 |
| 351265 | buprenorphine HCl 8 MG Sublingual Tablet | PSN | 593c2a50-de4f-6bf8-e053-2a91aa0ae306 | 1 |
| 351264 | buprenorphine 2 MG Sublingual Tablet | SCD | 593c2a50-de4f-6bf8-e053-2a91aa0ae306 | 1 |
| 351265 | buprenorphine 8 MG Sublingual Tablet | SCD | 593c2a50-de4f-6bf8-e053-2a91aa0ae306 | 1 |
| 351264 | buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual Tablet | SY | 593c2a50-de4f-6bf8-e053-2a91aa0ae306 | 1 |
| 351265 | buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual Tablet | SY | 593c2a50-de4f-6bf8-e053-2a91aa0ae306 | 1 |