Buprenorphine HCl
- Product NDC
- 31722-870
- 11-digit product format
- 317220870
- Labeler code
- 31722
- Product ID
- 31722-870_80bd7b21-6679-4dbb-84dd-f755c7a90166
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine HCl
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA219401
- Marketing category
- ANDA
- Marketing start
- 2026-01-12
- Substance
- BUPRENORPHINE HYDROCHLORIDE
- Active strength
- 2 mg/1
- 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
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 |
|---|---|---|---|---|---|---|
| 31722-870-30 | Buprenorphine HCl | 30 in 1 BOTTLE | TABLET | 30 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 351264 | buprenorphine HCl 2 MG Sublingual Tablet | PSN | b52cea0e-688f-4beb-bf7d-f228b81dbd23 | 1 |
| 351265 | buprenorphine HCl 8 MG Sublingual Tablet | PSN | b52cea0e-688f-4beb-bf7d-f228b81dbd23 | 1 |
| 351264 | buprenorphine 2 MG Sublingual Tablet | SCD | b52cea0e-688f-4beb-bf7d-f228b81dbd23 | 1 |
| 351265 | buprenorphine 8 MG Sublingual Tablet | SCD | b52cea0e-688f-4beb-bf7d-f228b81dbd23 | 1 |
| 351264 | buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual Tablet | SY | b52cea0e-688f-4beb-bf7d-f228b81dbd23 | 1 |
| 351265 | buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual Tablet | SY | b52cea0e-688f-4beb-bf7d-f228b81dbd23 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 31722-870-30 | 31722087030 | 30 TABLET in 1 BOTTLE (31722-870-30) | 30 tablet | 2026-01-12 | No | No | Historical |