Buprenorphine Hydrochloride
- Product NDC
- 0409-2012
- 11-digit product format
- 004092012
- Labeler code
- 0409
- Product ID
- 0409-2012_37d2deb6-c54a-42bb-ad76-4873a59da562
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA074137
- Marketing category
- ANDA
- Marketing start
- 2005-06-14
- Substance
- BUPRENORPHINE HYDROCHLORIDE
- Active strength
- .3 mg/mL
- 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 Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPRENORPHINE HYDROCHLORIDE | .3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 56W8MW3EN1 |
| Rxcui | 1655032 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0409-2012-03 | Buprenorphine Hydrochloride | 1 mL in 1 CARTRIDGE | INJECTION, SOLUTION | 1 | | 20 |
| 0409-2012-32 | Buprenorphine Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BUPRENORPHINE HYDROCHLORIDE | ACTIVE INGREDIENT | 56W8MW3EN1 | BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 10 | |
| Buprenorphine | ACTIVE MOIETY | 40D3SCR4GZ | BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 10 | |
| ANHYDROUS DEXTROSE | INACTIVE INGREDIENT | 5SL0G7R0OK | BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 10 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 10 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 10 | |
| BUPRENORPHINE HYDROCHLORIDE | ACTIVE INGREDIENT | 56W8MW3EN1 | BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| Buprenorphine | ACTIVE MOIETY | 40D3SCR4GZ | BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| ANHYDROUS DEXTROSE | INACTIVE INGREDIENT | 5SL0G7R0OK | BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-2012 | BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 19 | Current NDC, Legacy NDC, 2 package rows | 20240726_23aa1bb3-cecf-4e62-29bb-48488bb66fc3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0409-2012-03 | 00409201203 | 1 mL in 1 CARTRIDGE | 1 ml | | | | | Historical |
| 0409-2012-32 | 00409201232 | 10 CARTRIDGE in 1 CARTON (0409-2012-32) / 1 mL in 1 CARTRIDGE (0409-2012-03) | 10 cartridge | 2005-06-14 | 0000-00-00 | No | No | Current |