Haloperidol Decanoate
- Product NDC
- 72485-521
- 11-digit product format
- 724850521
- Labeler code
- 72485
- Product ID
- 72485-521_a5292afc-0881-42ad-a8d5-963f0946f104
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Haloperidol Decanoate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Armas Pharmaceuticals Inc.
- Application
- ANDA219168
- Marketing category
- ANDA
- Marketing start
- 2026-05-15
- 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 | 1719803 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72485-521-01 | Haloperidol Decanoate | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | | 1 |
| 72485-521-10 | Haloperidol Decanoate | 10 in 1 CARTON | INJECTION | 10 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72485-521-01 | 72485052101 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | Historical |
| 72485-521-10 | 72485052110 | 10 VIAL, SINGLE-DOSE in 1 CARTON (72485-521-10) / 1 mL in 1 VIAL, SINGLE-DOSE (72485-521-01) | | 2026-05-15 | No | No | Current |