Haloperidol

Product NDC
70518-0035
11-digit product format
705180035
Labeler code
70518
Product ID
70518-0035_4cd54384-6fbc-ee88-e063-6294a90aa4ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HALOPERIDOL LACTATE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
REMEDYREPACK INC.
Application
ANDA075689
Marketing category
ANDA
Marketing start
2016-12-02
Substance
HALOPERIDOL LACTATE
Active strength
5 mg/mL
Pharmacologic classes
Typical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Haloperidol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HALOPERIDOL LACTATE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6387S86PK3
Rxcui1719646

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d599bae4-cb25-0798-7468-31aa188fb750Product name720260304
6aae29ef-bf3c-3ebb-3bf1-10ee5424a22eProduct name220250114
af58e43a-5792-c2c1-8e57-a2454df1f2c0Product name320240202
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
ce329990-eb12-45a5-87d5-ce5ef054ca71Product name220190930
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0035-0Haloperidol25 in 1 TRAYINJECTION, SOLUTION2516
70518-0035-0Haloperidol1 mL in 1 VIALINJECTION, SOLUTION116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-0035-0ML - Milliliter70518-0035dc4bc641-c4e7-45a7-afc9-d87285649a2412026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0035HALOPERIDOL (HALOPERIDOL LACTATE) INJECTION, SOLUTION [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 2 package rows20250524_e702b2f0-d464-41c3-977a-d37bb22c0ab0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1719646haloperidol 5 MG in 1 ML InjectionPSNe702b2f0-d464-41c3-977a-d37bb22c0ab016
17196461 ML haloperidol 5 MG/ML InjectionSCDe702b2f0-d464-41c3-977a-d37bb22c0ab016
1719646haloperidol (as haloperidol lactate) 5 MG per 1 ML InjectionSYe702b2f0-d464-41c3-977a-d37bb22c0ab016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-0035-07051800350025 VIAL in 1 TRAY (70518-0035-0) / 1 mL in 1 VIAL25 vial2016-12-02NoNoCurrent