Haloperidol decanoate
- Product NDC
- 68001-657
- 11-digit product format
- 680010657
- Labeler code
- 68001
- Product ID
- 68001-657_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
- 50 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 |
|---|---|
| HALOPERIDOL DECANOATE | 50 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | AC20PJ4101 |
| Rxcui | 859871, 1719803, 1719862 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d599bae4-cb25-0798-7468-31aa188fb750 | Product name | 7 | 20260304 |
| 6aae29ef-bf3c-3ebb-3bf1-10ee5424a22e | Product name | 2 | 20250114 |
| af58e43a-5792-c2c1-8e57-a2454df1f2c0 | Product name | 3 | 20240202 |
| ce329990-eb12-45a5-87d5-ce5ef054ca71 | Product name | 2 | 20190930 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68001-657-41 | Haloperidol decanoate | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | 6 | |
| 68001-657-51 | Haloperidol decanoate | 3 in 1 CARTON | INJECTION | 3 | 6 | |
| 68001-657-56 | Haloperidol decanoate | 10 in 1 CARTON | INJECTION | 10 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68001-657-41 | ML - Milliliter | 68001-657 | 4fe2cd4f-0ab4-49d8-ba8b-f6e274239857 | 1 | 2025-08-11 |
| 68001-657-51 | ML - Milliliter | 68001-657 | c9311f6a-73e4-4388-88a0-4ac0650bc702 | 1 | 2025-08-11 |
| 68001-657-56 | ML - Milliliter | 68001-657 | 0ebe206d-713c-4181-9037-dc9a29c27328 | 1 | 2025-08-11 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1719803 | haloperidol decanoate 100 MG in 1 ML Injection | PSN | 3d011250-a517-4c27-8ce3-d59d441ea61c | 6 |
| 859871 | haloperidol decanoate 100 MG/ML Injectable Solution | PSN | 3d011250-a517-4c27-8ce3-d59d441ea61c | 6 |
| 1719862 | haloperidol decanoate 50 MG in 1 ML Injection | PSN | 3d011250-a517-4c27-8ce3-d59d441ea61c | 6 |
| 1719803 | 1 ML haloperidol decanoate 100 MG/ML Injection | SCD | 3d011250-a517-4c27-8ce3-d59d441ea61c | 6 |
| 1719862 | 1 ML haloperidol decanoate 50 MG/ML Injection | SCD | 3d011250-a517-4c27-8ce3-d59d441ea61c | 6 |
| 859871 | haloperidol decanoate 100 MG/ML Injectable Solution | SCD | 3d011250-a517-4c27-8ce3-d59d441ea61c | 6 |
| 859871 | haloperidol 100 MG/ML (as haloperidol decanoate) Injectable Solution | SY | 3d011250-a517-4c27-8ce3-d59d441ea61c | 6 |
| 1719803 | haloperidol decanoate 100 MG per 1 ML Injection | SY | 3d011250-a517-4c27-8ce3-d59d441ea61c | 6 |
| 1719862 | haloperidol decanoate 50 MG per 1 ML Injection | SY | 3d011250-a517-4c27-8ce3-d59d441ea61c | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68001-657-41 | 68001065741 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | Historical | |||
| 68001-657-51 | 68001065751 | 3 VIAL, SINGLE-DOSE in 1 CARTON (68001-657-51) / 1 mL in 1 VIAL, SINGLE-DOSE (68001-657-41) | 2025-10-01 | No | No | Historical | |
| 68001-657-56 | 68001065756 | 10 in 1 CARTON | Historical |