Haloperidol Decanoate
- Product NDC
- 68083-137
- 11-digit product format
- 680830137
- Labeler code
- 68083
- Product ID
- 68083-137_da8f2d81-a122-4fe4-8f43-f2fe611d69c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Haloperidol Decanoate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Gland Pharma Limited
- Application
- ANDA205241
- Marketing category
- ANDA
- Marketing start
- 2017-01-16
- Substance
- HALOPERIDOL DECANOATE
- Active strength
- 50 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 | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AC20PJ4101 |
| Rxcui | 859867, 859871, 1719803, 1719862 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-137-02 | Haloperidol Decanoate | 1 in 1 CARTON | INJECTION | 1 | | 14 |
| 68083-137-02 | Haloperidol Decanoate | 5 mL in 1 VIAL | INJECTION | 5 | | 14 |
| 68083-137-10 | Haloperidol Decanoate | 10 in 1 CARTON | INJECTION | 10 | | 14 |
| 68083-137-10 | Haloperidol Decanoate | 1 mL in 1 VIAL | INJECTION | 1 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-137 | HALOPERIDOL DECANOATE INJECTION [GLAND PHARMA LIMITED] | 12 | Current NDC, Legacy NDC, 4 package rows | 20250223_1a0e38cb-fd9f-4962-9f81-5c0023ca6b4c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68083-137-02 | 68083013702 | 1 VIAL in 1 CARTON (68083-137-02) / 5 mL in 1 VIAL | 1 vial | 2017-01-16 | 0000-00-00 | No | No | Current |
| 68083-137-10 | 68083013710 | 10 VIAL in 1 CARTON (68083-137-10) / 1 mL in 1 VIAL | 10 vial | 2017-01-16 | 0000-00-00 | No | No | Current |