Barhemsys
- Product NDC
- 71390-125
- 11-digit product format
- 713900125
- Labeler code
- 71390
- Product ID
- 71390-125_b4cf2d39-67e7-459b-add4-5454b1029c14
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amisulpride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Acacia Pharma Ltd
- Application
- NDA209510
- Marketing category
- NDA
- Marketing start
- 2020-02-27
- Substance
- AMISULPRIDE
- Active strength
- 2.5 mg/mL
- Pharmacologic classes
- Dopamine D2 Antagonists [MoA], Dopamine-2 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Barhemsys
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMISULPRIDE | 2.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8110R61I4U |
| Rxcui | 2284232, 2284237, 2467148, 2467149 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71390-125-20 | Barhemsys | 10 in 1 PACKAGE | INJECTION, SOLUTION | 10 | | 7 |
| 71390-125-21 | Barhemsys | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 7 |
| 71390-125-21 | Barhemsys | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 2 | | 7 |
| 71390-125-50 | Barhemsys | 10 in 1 PACKAGE | INJECTION, SOLUTION | 10 | | 7 |
| 71390-125-51 | Barhemsys | 4 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 4 | | 7 |
| 71390-125-51 | Barhemsys | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71390-125 | BARHEMSYS (AMISULPRIDE) INJECTION, SOLUTION [ACACIA PHARMA LTD] | 6 | Current NDC, Legacy NDC, 6 package rows | 20220929_ab23bc6e-b6a8-165f-e053-2a95a90ab144.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 |
|---|
| 71390-125-20 | 71390012520 | 10 CARTON in 1 PACKAGE (71390-125-20) / 1 VIAL, SINGLE-DOSE in 1 CARTON (71390-125-21) / 2 mL in 1 VIAL, SINGLE-DOSE | 10 carton | 2020-02-27 | 0000-00-00 | No | No | Current |
| 71390-125-21 | 71390012521 | 1 in 1 CARTON | | | | | | Historical |
| 71390-125-50 | 71390012550 | 10 CARTON in 1 PACKAGE (71390-125-50) / 1 VIAL, SINGLE-DOSE in 1 CARTON (71390-125-51) / 4 mL in 1 VIAL, SINGLE-DOSE | 10 carton | 2020-02-27 | 0000-00-00 | No | No | Current |
| 71390-125-51 | 71390012551 | 4 mL in 1 VIAL, SINGLE-DOSE | 4 ml | | | | | Historical |