Haloperidol Decanoate
- Product NDC
- 71288-504
- 11-digit product format
- 712880504
- Labeler code
- 71288
- Product ID
- 71288-504_2cbc95d6-a15f-431f-9ff0-4827251bb767
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Haloperidol Decanoate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA214507
- Marketing category
- ANDA
- Marketing start
- 2021-07-26
- 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 |
|---|
| 71288-504-05 | Haloperidol Decanoate | 1 in 1 CARTON | INJECTION | 1 | | 6 |
| 71288-504-05 | Haloperidol Decanoate | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION | 5 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71288-504 | HALOPERIDOL DECANOATE INJECTION [MEITHEAL PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250426_14f40303-9604-4a30-8e86-8abaeb177ce1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71288-504-05 | 71288050405 | 1 VIAL, MULTI-DOSE in 1 CARTON (71288-504-05) / 5 mL in 1 VIAL, MULTI-DOSE | 2021-07-26 | 0000-00-00 | No | No | Current |