FDA.reportPublic FDA data

Haloperidol

Product NDC
70756-004
11-digit product format
707560004
Labeler code
70756
Product ID
70756-004_7b545974-2d39-4106-8975-76c124a6c5ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
haloperidol
Dosage form
TABLET
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA216918
Marketing category
ANDA
Marketing start
2024-04-11
Substance
HALOPERIDOL
Active strength
5 mg/1
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
IngredientStrength
HALOPERIDOL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ6292F8L3D
Rxcui197754, 310670, 310671, 310672, 314034, 314035

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
70756-004-11Haloperidol100 in 1 BOTTLETABLET1005
70756-004-12Haloperidol1000 in 1 BOTTLETABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-004-11EA - Each70756-004ffa0a1b0-73cb-48c8-b86a-2d1fb7cbc77c12024-06-10
70756-004-12EA - Each70756-004ec0bccaf-17ae-46eb-819c-211263677ffd12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-004HALOPERIDOL TABLET [LIFESTAR PHARMA LLC]5Current NDC, 2 package rows20241121_00bb61c8-db35-4c04-9ef7-47d447d2496b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310670haloperidol 0.5 MG Oral TabletPSN00bb61c8-db35-4c04-9ef7-47d447d2496b5
310671haloperidol 1 MG Oral TabletPSN00bb61c8-db35-4c04-9ef7-47d447d2496b5
314035haloperidol 10 MG Oral TabletPSN00bb61c8-db35-4c04-9ef7-47d447d2496b5
314034haloperidol 2 MG Oral TabletPSN00bb61c8-db35-4c04-9ef7-47d447d2496b5
197754haloperidol 20 MG Oral TabletPSN00bb61c8-db35-4c04-9ef7-47d447d2496b5
310672haloperidol 5 MG Oral TabletPSN00bb61c8-db35-4c04-9ef7-47d447d2496b5
310670haloperidol 0.5 MG Oral TabletSCD00bb61c8-db35-4c04-9ef7-47d447d2496b5
310671haloperidol 1 MG Oral TabletSCD00bb61c8-db35-4c04-9ef7-47d447d2496b5
314035haloperidol 10 MG Oral TabletSCD00bb61c8-db35-4c04-9ef7-47d447d2496b5
314034haloperidol 2 MG Oral TabletSCD00bb61c8-db35-4c04-9ef7-47d447d2496b5
197754haloperidol 20 MG Oral TabletSCD00bb61c8-db35-4c04-9ef7-47d447d2496b5
310672haloperidol 5 MG Oral TabletSCD00bb61c8-db35-4c04-9ef7-47d447d2496b5
314035haloperidol 10 MG Oral TabletPSN8743da03-67f1-4cb0-8159-45141cb5466e2
310672haloperidol 5 MG Oral TabletPSN8743da03-67f1-4cb0-8159-45141cb5466e2
310672haloperidol 5 MG Oral TabletPSNa0751f2e-05ab-4ba9-9bae-7b791bf1a6212
314035haloperidol 10 MG Oral TabletSCD8743da03-67f1-4cb0-8159-45141cb5466e2
310672haloperidol 5 MG Oral TabletSCD8743da03-67f1-4cb0-8159-45141cb5466e2
310672haloperidol 5 MG Oral TabletSCDa0751f2e-05ab-4ba9-9bae-7b791bf1a6212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70756-004-1170756000411100 TABLET in 1 BOTTLE (70756-004-11) 100 tablet2024-04-11NoNoHistorical
70756-004-12707560004121000 TABLET in 1 BOTTLE (70756-004-12) 1000 tablet2024-04-11NoNoHistorical