Haloperidol
- Product NDC
- 54838-501
- 11-digit product format
- 548380501
- Labeler code
- 54838
- Product ID
- 54838-501_898ee841-bdf7-4306-ac5c-282e522afd9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Haloperidol
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA073364
- Marketing category
- ANDA
- Marketing start
- 1993-09-28
- Substance
- HALOPERIDOL LACTATE
- Active strength
- 2 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 |
|---|---|
| HALOPERIDOL LACTATE | 2 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 6387S86PK3 |
| Rxcui | 141935 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d599bae4-cb25-0798-7468-31aa188fb750 | Product name | 7 | 20260304 |
| 6aae29ef-bf3c-3ebb-3bf1-10ee5424a22e | Product name | 2 | 20250114 |
| af58e43a-5792-c2c1-8e57-a2454df1f2c0 | Product name | 3 | 20240202 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| ce329990-eb12-45a5-87d5-ce5ef054ca71 | Product name | 2 | 20190930 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 597b1cfd-7b31-5048-62be-ca5cd740da2f | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54838-501-15 | Haloperidol | 15 mL in 1 BOTTLE, DROPPER | SOLUTION | 15 | 29 | |
| 54838-501-40 | Haloperidol | 120 mL in 1 BOTTLE, DROPPER | SOLUTION | 120 | 29 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54838-501-15 | ML - Milliliter | 54838-501 | 40579a8c-fe01-4204-a199-524c8fccb4b7 | 1 | 2012-07-24 |
| 54838-501-40 | ML - Milliliter | 54838-501 | 70a789b4-2c52-4a8d-8563-7023bbb1eb1e | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Haloperidol Lactate | ACTIVE INGREDIENT | 6387S86PK3 | HALOPERIDOL SOLUTION [SILARX PHARMACEUTICALS, INC] | 15 | |
| Haloperidol | ACTIVE MOIETY | J6292F8L3D | HALOPERIDOL SOLUTION [SILARX PHARMACEUTICALS, INC] | 15 | |
| lactic acid | INACTIVE INGREDIENT | 33X04XA5AT | HALOPERIDOL SOLUTION [SILARX PHARMACEUTICALS, INC] | 15 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | HALOPERIDOL SOLUTION [SILARX PHARMACEUTICALS, INC] | 15 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | HALOPERIDOL SOLUTION [SILARX PHARMACEUTICALS, INC] | 15 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | HALOPERIDOL SOLUTION [SILARX PHARMACEUTICALS, INC] | 15 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | HALOPERIDOL SOLUTION [SILARX PHARMACEUTICALS, INC] | 15 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 141935 | haloperidol 2 MG in 1 mL Concentrate for Oral Solution | PSN | 3e44fed0-6132-4881-a9cd-af6156c7af9c | 29 |
| 141935 | haloperidol 2 MG/ML Oral Solution | SCD | 3e44fed0-6132-4881-a9cd-af6156c7af9c | 29 |
| 141935 | haloperidol 2 MG per 1 ML Concentrate for Oral Solution | SY | 3e44fed0-6132-4881-a9cd-af6156c7af9c | 29 |
| 141935 | haloperidol 2 MG in 1 mL Concentrate for Oral Solution | PSN | 3766e48c-4bd3-448c-a526-06a347ea8f5a | 1 |
| 141935 | haloperidol 2 MG/ML Oral Solution | SCD | 3766e48c-4bd3-448c-a526-06a347ea8f5a | 1 |
| 141935 | haloperidol 2 MG per 1 ML Concentrate for Oral Solution | SY | 3766e48c-4bd3-448c-a526-06a347ea8f5a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 54838-501-15 | 54838050115 | 15 mL in 1 BOTTLE, DROPPER (54838-501-15) | 15 ml | 1993-09-28 | 0000-00-00 | No | No | Current |
| 54838-501-40 | 54838050140 | 120 mL in 1 BOTTLE, DROPPER (54838-501-40) | 120 ml | 1993-09-28 | 0000-00-00 | No | No | Current |