Haloperidol decanoate
- Product NDC
- 68001-658
- 11-digit product format
- 680010658
- Labeler code
- 68001
- Product ID
- 68001-658_4dc563ca-3dbe-0ca5-e063-6394a90ad276
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Haloperidol decanoate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- BluePoint Laboratories
- Application
- ANDA211180
- Marketing category
- ANDA
- Marketing start
- 2025-06-12
- Substance
- HALOPERIDOL DECANOATE
- Active strength
- 100 mg/mL
- Pharmacologic classes
- Typical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Haloperidol decanoate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HALOPERIDOL DECANOATE | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AC20PJ4101 |
| Rxcui | 859871, 1719803, 1719862 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68001-658-41 | Haloperidol decanoate | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | | 6 |
| 68001-658-41 | Haloperidol decanoate | 1 in 1 CARTON | INJECTION | 1 | | 6 |
| 68001-658-52 | Haloperidol decanoate | 5 in 1 CARTON | INJECTION | 5 | | 6 |
| 68001-658-52 | Haloperidol decanoate | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | | 6 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68001-658-41 | 68001065841 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-658-41) / 1 mL in 1 VIAL, SINGLE-DOSE | 2025-09-30 | No | No | Historical |
| 68001-658-52 | 68001065852 | 5 VIAL, SINGLE-DOSE in 1 CARTON (68001-658-52) / 1 mL in 1 VIAL, SINGLE-DOSE | 2025-10-01 | No | No | Historical |