Haloperidol Decanoate
- Product NDC
- 65145-169
- 11-digit product format
- 651450169
- Labeler code
- 65145
- Product ID
- 65145-169_4f9af14a-38c4-4826-aca0-3501edb854e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Haloperidol Decanoate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Caplin Steriles Limited
- Application
- ANDA219168
- Marketing category
- ANDA
- Marketing start
- 2025-05-26
- 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 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 |
|---|
| 65145-169-01 | Haloperidol Decanoate | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION | 5 | | 1 |
| 65145-169-01 | Haloperidol Decanoate | 1 in 1 CARTON | INJECTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65145-169 | HALOPERIDOL DECANOATE INJECTION [CAPLIN STERILES LIMITED] | 1 | Current NDC, 2 package rows | 20250528_4f9af14a-38c4-4826-aca0-3501edb854e3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 65145-169-01 | 65145016901 | 1 VIAL, MULTI-DOSE in 1 CARTON (65145-169-01) / 5 mL in 1 VIAL, MULTI-DOSE | 2025-05-26 | No | No | Current |