FDA.reportPublic FDA data

AHIST

Product NDC
58407-025
11-digit product format
584070025
Labeler code
58407
Product ID
58407-025_938dae00-2ce6-40bc-84a5-45407d327bc1
Type
HUMAN OTC DRUG
Nonproprietary name
CHLORCYCLIZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Magna Pharmaceutcals, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-01-15
Marketing end
0000-00-00
Substance
CHLORCYCLIZINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58407-025-062023-07-28C16284748780-1ba0f9c33-1455-a910-e053-dadaa90a0b85AHIST™
58407-025-302023-07-28C16284748780-1ba0f9c33-1455-a910-e053-dadaa90a0b85AHIST™
58407-025-062022-08-17C16284748780-1ba0f9c33-1455-a910-e053-dadaa90a0b85AHIST™
58407-025-302022-08-17C16284748780-1ba0f9c33-1455-a910-e053-dadaa90a0b85AHIST™
58407-025-062021-01-29C16284748780-1ba0f9c33-1455-a910-e053-dadaa90a0b85AHIST™
58407-025-302021-01-29C16284748780-1ba0f9c33-1455-a910-e053-dadaa90a0b85AHIST™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58407-025-01AHIST1 in 1 BLISTER PACKTABLET14
58407-025-06AHIST6 in 1 BOXTABLET64
58407-025-30AHIST30 in 1 BOXTABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58407-025-01EA - Each58407-025eed65d21-07a4-4b36-9602-d7195ff4a61912022-06-06
58407-025-30EA - Each58407-0258b9cd244-5c50-4208-a7ef-bd7b0cc53cbf12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORCYCLIZINE HYDROCHLORIDEACTIVE INGREDIENTNPB7A7874UAHIST (CHLORCYCLIZINE HYDROCHLORIDE) TABLET [MAGNA PHARMACEUTCALS, INC.]1
CHLORCYCLIZINEACTIVE MOIETYM26C4IP44PAHIST (CHLORCYCLIZINE HYDROCHLORIDE) TABLET [MAGNA PHARMACEUTCALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAHIST (CHLORCYCLIZINE HYDROCHLORIDE) TABLET [MAGNA PHARMACEUTCALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AHIST (CHLORCYCLIZINE HYDROCHLORIDE) TABLET [MAGNA PHARMACEUTCALS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AHIST (CHLORCYCLIZINE HYDROCHLORIDE) TABLET [MAGNA PHARMACEUTCALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58407-025AHIST (CHLORCYCLIZINE HYDROCHLORIDE) TABLET [MAGNA PHARMACEUTCALS, INC.]4Legacy NDC, 3 package rows20220819_d50b5154-20a3-4c5b-ad7b-08c081340b12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366500Ahist Antihistamine 25 MG Oral TabletPSNd50b5154-20a3-4c5b-ad7b-08c081340b124
1366494chlorcyclizine HCl 25 MG Oral TabletPSNd50b5154-20a3-4c5b-ad7b-08c081340b124
1366500chlorcyclizine hydrochloride 25 MG Oral Tablet [Ahist Antihistamine]SBDd50b5154-20a3-4c5b-ad7b-08c081340b124
1366494chlorcyclizine hydrochloride 25 MG Oral TabletSCDd50b5154-20a3-4c5b-ad7b-08c081340b124
1366500Ahist Antihistamine 25 MG Oral TabletSYd50b5154-20a3-4c5b-ad7b-08c081340b124

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58407-025-01584070025011 in 1 BLISTER PACKHistorical
58407-025-06584070025066 in 1 BOXHistorical
58407-025-305840700253030 BLISTER PACK in 1 BOX (58407-025-30) > 1 TABLET in 1 BLISTER PACK (58407-025-01) 30 blister pack2013-01-150000-00-00NoNoCurrent