HALOPERIDOL DECANOATE
- Product NDC
- 70069-382
- 11-digit product format
- 700690382
- Labeler code
- 70069
- Product ID
- 70069-382_f6d888a0-65a7-4073-8671-b00b4bfaff4c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HALOPERIDOL DECANOATE
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA209101
- Marketing category
- ANDA
- Marketing start
- 2019-04-04
- 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 |
|---|
| 70069-382-01 | HALOPERIDOL DECANOATE | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION | 5 | | 19 |
| 70069-382-01 | HALOPERIDOL DECANOATE | 1 in 1 CARTON | INJECTION | 1 | | 19 |
| 70069-382-05 | HALOPERIDOL DECANOATE | 5 in 1 CARTON | INJECTION | 5 | | 19 |
| 70069-382-05 | HALOPERIDOL DECANOATE | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION | 5 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-382 | HALOPERIDOL DECANOATE INJECTION [SOMERSET THERAPEUTICS, LLC] | 19 | Current NDC, Legacy NDC, 4 package rows | 20231219_f2bff27f-929f-4f7d-b3eb-084ebc2a885f.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 |
|---|
| 70069-382-01 | 70069038201 | 1 VIAL, MULTI-DOSE in 1 CARTON (70069-382-01) / 5 mL in 1 VIAL, MULTI-DOSE | 2019-04-13 | 0000-00-00 | No | No | Current |
| 70069-382-05 | 70069038205 | 5 VIAL, MULTI-DOSE in 1 CARTON (70069-382-05) / 5 mL in 1 VIAL, MULTI-DOSE | 2020-04-04 | 0000-00-00 | No | No | Current |