Haloperidol
- Product NDC
- 63323-474
- 11-digit product format
- 633230474
- Labeler code
- 63323
- Product ID
- 63323-474_f3409439-088d-49ec-9e10-c6c3b1a07eef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HALOPERIDOL LACTATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA075689
- Marketing category
- ANDA
- Marketing start
- 2000-10-20
- Substance
- HALOPERIDOL LACTATE
- Active strength
- 5 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HALOPERIDOL LACTATE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6387S86PK3 |
| Rxcui | 204416, 1719646 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-474-00 | Haloperidol | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 11 |
| 63323-474-01 | Haloperidol | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 11 |
| 63323-474-10 | Haloperidol | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 11 |
| 63323-474-10 | Haloperidol | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HALOPERIDOL LACTATE | ACTIVE INGREDIENT | 6387S86PK3 | HALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | |
| HALOPERIDOL | ACTIVE MOIETY | J6292F8L3D | HALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | |
| LACTIC ACID | INACTIVE INGREDIENT | 33X04XA5AT | HALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | HALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | HALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | |
| HALOPERIDOL LACTATE | ACTIVE INGREDIENT | 6387S86PK3 | HALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [CARDINAL HEALTH] | 3 | |
| HALOPERIDOL | ACTIVE MOIETY | J6292F8L3D | HALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [CARDINAL HEALTH] | 3 | |
| LACTIC ACID | INACTIVE INGREDIENT | 33X04XA5AT | HALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [CARDINAL HEALTH] | 3 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | HALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [CARDINAL HEALTH] | 3 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | HALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [CARDINAL HEALTH] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-474 | HALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] | 11 | Current NDC, Legacy NDC, 4 package rows | 20220224_b1ad2abd-a9d6-44e3-957b-36a73260f4f5.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 |
|---|
| 63323-474-00 | 63323047400 | 1 mL in 1 VIAL | 1 ml | | | | | Historical |
| 63323-474-01 | 63323047401 | 25 VIAL in 1 TRAY (63323-474-01) / 1 mL in 1 VIAL (63323-474-00) | 25 vial | 2000-10-20 | 0000-00-00 | No | No | Current |
| 63323-474-10 | 63323047410 | 1 VIAL, MULTI-DOSE in 1 BOX (63323-474-10) / 10 mL in 1 VIAL, MULTI-DOSE | | 2000-10-20 | 0000-00-00 | No | No | Current |