HALOPERIDOL DECANOATE
- Product NDC
- 70069-868
- 11-digit product format
- 700690868
- Labeler code
- 70069
- Product ID
- 70069-868_75154f5d-21e4-4278-85f9-78a4a4e85741
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HALOPERIDOL DECANOATE
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA219168
- Marketing category
- ANDA
- Marketing start
- 2025-09-29
- Substance
- HALOPERIDOL DECANOATE
- Active strength
- 100 mg/mL
- Pharmacologic classes
- Typical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HALOPERIDOL DECANOATE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HALOPERIDOL DECANOATE | 100 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 |
|---|---|---|---|---|---|---|
| 70069-868-01 | HALOPERIDOL DECANOATE | 5 mL in 1 VIAL | INJECTION | 5 | 1 | |
| 70069-868-01 | HALOPERIDOL DECANOATE | 1 in 1 CARTON | INJECTION | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70069-868-01 | ML - Milliliter | 70069-868 | 31e4e9b6-4ee7-4a8d-b0ea-c608a6c95fd1 | 1 | 2025-11-13 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1719803 | haloperidol decanoate 100 MG in 1 ML Injection | PSN | 068fc913-779d-44c6-9585-3aa80e751bee | 1 |
| 859871 | haloperidol decanoate 100 MG/ML Injectable Solution | PSN | 068fc913-779d-44c6-9585-3aa80e751bee | 1 |
| 1719862 | haloperidol decanoate 50 MG in 1 ML Injection | PSN | 068fc913-779d-44c6-9585-3aa80e751bee | 1 |
| 1719803 | 1 ML haloperidol decanoate 100 MG/ML Injection | SCD | 068fc913-779d-44c6-9585-3aa80e751bee | 1 |
| 1719862 | 1 ML haloperidol decanoate 50 MG/ML Injection | SCD | 068fc913-779d-44c6-9585-3aa80e751bee | 1 |
| 859871 | haloperidol decanoate 100 MG/ML Injectable Solution | SCD | 068fc913-779d-44c6-9585-3aa80e751bee | 1 |
| 859871 | haloperidol 100 MG/ML (as haloperidol decanoate) Injectable Solution | SY | 068fc913-779d-44c6-9585-3aa80e751bee | 1 |
| 1719803 | haloperidol decanoate 100 MG per 1 ML Injection | SY | 068fc913-779d-44c6-9585-3aa80e751bee | 1 |
| 1719862 | haloperidol decanoate 50 MG per 1 ML Injection | SY | 068fc913-779d-44c6-9585-3aa80e751bee | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70069-868-01 | 70069086801 | 1 VIAL in 1 CARTON (70069-868-01) / 5 mL in 1 VIAL | 1 vial | 2025-09-29 | No | No | Current |