Haloperidol

Product NDC
70518-3587
11-digit product format
705183587
Labeler code
70518
Product ID
70518-3587_4f5bc1f8-5ae6-94f0-e063-6294a90ae5f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA071173
Marketing category
ANDA
Marketing start
2022-12-05
Substance
HALOPERIDOL
Active strength
10 mg/1
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
HALOPERIDOL10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ6292F8L3D
Rxcui314035

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
ce329990-eb12-45a5-87d5-ce5ef054ca71Product name220190930

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3587-0Haloperidol30 in 1 BLISTER PACKTABLET306
70518-3587-1Haloperidol100 in 1 BOXTABLET1006
70518-3587-2Haloperidol1 in 1 POUCHTABLET16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3587HALOPERIDOL TABLET [REMEDYREPACK INC.]3Current NDC, Legacy NDC, 3 package rows20240116_a3afd19a-c340-4fad-8ddd-d71242515345.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314035haloperidol 10 MG Oral TabletPSNa3afd19a-c340-4fad-8ddd-d712425153456
314035haloperidol 10 MG Oral TabletSCDa3afd19a-c340-4fad-8ddd-d712425153456

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3587-07051835870030 TABLET in 1 BLISTER PACK (70518-3587-0) 30 tablet2022-12-050000-00-00NoNoCurrent
70518-3587-170518358701100 POUCH in 1 BOX (70518-3587-1) / 1 TABLET in 1 POUCH (70518-3587-2) 100 pouch2026-01-05NoNoCurrent
70518-3587-2705183587021 in 1 POUCHHistorical