Buprenorphine HCl
- Product NDC
- 0406-7018
- 11-digit product format
- 004067018
- Labeler code
- 0406
- Product ID
- 0406-7018_12e82887-be89-46cd-a55a-46e9e2ef2cba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine HCl
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- SpecGx LLC
- Application
- ANDA218473
- Marketing category
- ANDA
- Marketing start
- 2026-01-19
- Substance
- BUPRENORPHINE HYDROCHLORIDE
- Active strength
- 8 mg/1
- 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 HCl
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUPRENORPHINE HYDROCHLORIDE | 8 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 56W8MW3EN1 |
| Rxcui | 351264, 351265 |
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 |
|---|---|---|---|---|---|---|
| 0406-7018-03 | Buprenorphine HCl | 30 in 1 BOTTLE | TABLET | 30 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0406-7018-03 | EA - Each | 0406-7018 | 85209ddc-c875-4750-b7b7-4cec2f0d103f | 1 | 2026-02-05 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 351264 | buprenorphine HCl 2 MG Sublingual Tablet | PSN | b60d514d-a88a-4fa2-a5b0-30ac29e04973 | 2 |
| 351265 | buprenorphine HCl 8 MG Sublingual Tablet | PSN | b60d514d-a88a-4fa2-a5b0-30ac29e04973 | 2 |
| 351264 | buprenorphine 2 MG Sublingual Tablet | SCD | b60d514d-a88a-4fa2-a5b0-30ac29e04973 | 2 |
| 351265 | buprenorphine 8 MG Sublingual Tablet | SCD | b60d514d-a88a-4fa2-a5b0-30ac29e04973 | 2 |
| 351264 | buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual Tablet | SY | b60d514d-a88a-4fa2-a5b0-30ac29e04973 | 2 |
| 351265 | buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual Tablet | SY | b60d514d-a88a-4fa2-a5b0-30ac29e04973 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0406-7018-03 | 00406701803 | 30 TABLET in 1 BOTTLE (0406-7018-03) | 30 tablet | 2026-01-19 | No | No | Historical |