Haldol Decanoate
- Product NDC
- 50458-253
- 11-digit product format
- 504580253
- Labeler code
- 50458
- Product ID
- 50458-253_43588a6b-8b38-dcaa-e063-6294a90a1666
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Haloperidol Decanoate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Janssen Pharmaceuticals, Inc.
- Application
- NDA018701
- Marketing category
- NDA
- Marketing start
- 1986-01-14
- Marketing end
- 2027-05-31
- Substance
- HALOPERIDOL DECANOATE
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Typical Antipsychotic [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Haldol Decanoate
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HALOPERIDOL DECANOATE | 50 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | AC20PJ4101 |
| Rxcui | 1719803, 1719847, 1719862, 1720026 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50458-253-01 | Haldol Decanoate | 1 mL in 1 AMPULE | INJECTION | 1 | 25 | |
| 50458-253-01 | Haldol Decanoate | 10 in 1 BOX | INJECTION | 10 | 25 | |
| 50458-253-03 | Haldol Decanoate | 3 in 1 BOX | INJECTION | 3 | 25 | |
| 50458-253-03 | Haldol Decanoate | 1 mL in 1 AMPULE | INJECTION | 1 | 25 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50458-253-03 | ML - Milliliter | 50458-253 | 67fb19f0-d329-4540-875c-0db335a2b234 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Haloperidol Decanoate | ACTIVE INGREDIENT | AC20PJ4101 | HALDOL DECANOATE (HALOPERIDOL DECANOATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.] | 10 | |
| Haloperidol | ACTIVE MOIETY | J6292F8L3D | HALDOL DECANOATE (HALOPERIDOL DECANOATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.] | 10 | |
| benzyl alcohol | INACTIVE INGREDIENT | LKG8494WBH | HALDOL DECANOATE (HALOPERIDOL DECANOATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.] | 10 | |
| sesame oil | INACTIVE INGREDIENT | QX10HYY4QV | HALDOL DECANOATE (HALOPERIDOL DECANOATE) INJECTION [JANSSEN PHARMACEUTICALS, INC.] | 10 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1719847 | Haldol Decanoate 100 MG in 1 ML Injection | PSN | af0159a8-dff5-449a-aa2b-a0c430081e21 | 25 |
| 1720026 | Haldol Decanoate 50 MG in 1 ML Injection | PSN | af0159a8-dff5-449a-aa2b-a0c430081e21 | 25 |
| 1719803 | haloperidol decanoate 100 MG in 1 ML Injection | PSN | af0159a8-dff5-449a-aa2b-a0c430081e21 | 25 |
| 1719862 | haloperidol decanoate 50 MG in 1 ML Injection | PSN | af0159a8-dff5-449a-aa2b-a0c430081e21 | 25 |
| 1719847 | 1 ML haloperidol decanoate 100 MG/ML Injection [Haldol] | SBD | af0159a8-dff5-449a-aa2b-a0c430081e21 | 25 |
| 1720026 | 1 ML haloperidol decanoate 50 MG/ML Injection [Haldol] | SBD | af0159a8-dff5-449a-aa2b-a0c430081e21 | 25 |
| 1719803 | 1 ML haloperidol decanoate 100 MG/ML Injection | SCD | af0159a8-dff5-449a-aa2b-a0c430081e21 | 25 |
| 1719862 | 1 ML haloperidol decanoate 50 MG/ML Injection | SCD | af0159a8-dff5-449a-aa2b-a0c430081e21 | 25 |
| 1719847 | 1 ML Haldol 100 MG/ML Injection | SY | af0159a8-dff5-449a-aa2b-a0c430081e21 | 25 |
| 1720026 | 1 ML Haldol 50 MG/ML Injection | SY | af0159a8-dff5-449a-aa2b-a0c430081e21 | 25 |
| 1719847 | Haldol Decanoate 100 MG per 1 ML Injection | SY | af0159a8-dff5-449a-aa2b-a0c430081e21 | 25 |
| 1720026 | Haldol Decanoate 50 MG per 1 ML Injection | SY | af0159a8-dff5-449a-aa2b-a0c430081e21 | 25 |
| 1719803 | haloperidol decanoate 100 MG per 1 ML Injection | SY | af0159a8-dff5-449a-aa2b-a0c430081e21 | 25 |
| 1719862 | haloperidol decanoate 50 MG per 1 ML Injection | SY | af0159a8-dff5-449a-aa2b-a0c430081e21 | 25 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50458-253-01 | 50458025301 | 1 mL in 1 AMPULE | 1 ml | Historical | ||||
| 50458-253-03 | 50458025303 | 3 AMPULE in 1 BOX (50458-253-03) / 1 mL in 1 AMPULE | 3 ampule | 1986-01-14 | 2027-05-31 | No | No | Current |