FDA.reportPublic FDA data

HALOPERIDOL

Product NDC
61919-133
11-digit product format
619190133
Labeler code
61919
Product ID
61919-133_9c9728d1-a596-556a-e053-2995a90a5994
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HALOPERIDOL
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA077580
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
HALOPERIDOL
Active strength
5 mg/1
Pharmacologic classes
Typical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-133-302023-01-30C16284748780-1f386c649-d4e8-0266-e053-dadaa90a7c1a​HALOPERIDOL​

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-133-30HALOPERIDOL30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-133-30EA - Each61919-133d4212eef-ddd9-4ba3-be2b-4b021417491b12015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HALOPERIDOLACTIVE INGREDIENTJ6292F8L3DHALOPERIDOL TABLET [DIRECT RX]1
HALOPERIDOLACTIVE MOIETYJ6292F8L3DHALOPERIDOL TABLET [DIRECT RX]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LHALOPERIDOL TABLET [DIRECT RX]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHALOPERIDOL TABLET [DIRECT RX]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPHALOPERIDOL TABLET [DIRECT RX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHALOPERIDOL TABLET [DIRECT RX]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XHALOPERIDOL TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HALOPERIDOL TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHALOPERIDOL TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-133HALOPERIDOL TABLET [DIRECT RX]3Legacy NDC, 1 package rows20200121_da0be2a5-b6f3-4e08-83e8-84b0985de497.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310672haloperidol 5 MG Oral TabletPSNda0be2a5-b6f3-4e08-83e8-84b0985de4973
310672haloperidol 5 MG Oral TabletSCDda0be2a5-b6f3-4e08-83e8-84b0985de4973

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-133-306191901333030 TABLET in 1 BOTTLE (61919-133-30) 30 tablet2015-01-010000-00-00NoNoCurrent