HYDROXYZINE HCL

Product NDC
61919-217
11-digit product format
619190217
Labeler code
61919
Product ID
61919-217_eac3b1b0-6bfc-f549-e053-2a95a90ac25d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYZINE HCL
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA204279
Marketing category
ANDA
Marketing start
2017-10-30
Marketing end
0000-00-00
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57311cfb-679a-da1a-b70c-8757f7fc431aProduct name420250516
aa1826f4-97c1-4705-bdf0-3bc7d234e618Product name220190618
75cb12ee-8eb2-4f1a-a332-5743a5d0da41Product name120151110
3ca5f78b-43dc-30fe-8014-55b922af52b3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-217-15HYDROXYZINE HCL15 in 1 BOTTLETABLET1510
61919-217-30HYDROXYZINE HCL30 in 1 BOTTLETABLET3010
61919-217-60HYDROXYZINE HCL60 in 1 BOTTLETABLET6010
61919-217-90HYDROXYZINE HCL90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-217-30EA - Each61919-21788f91568-37c1-4352-9de8-a0c65d766a3f12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-217HYDROXYZINE HCL TABLET HYDROXYZINE HCL TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]10Legacy NDC, 3 package rows20230414_5cc3aaa6-e18f-a116-e053-2991aa0a1422.zip
61919-217HYDROXYZINE HCL TABLET [DIRECT RX]1Legacy NDC, 1 package rows20171018_5bd46f87-5e1a-2d23-e053-2a91aa0a8959.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN5cc3aaa6-e18f-a116-e053-2991aa0a142210
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD5cc3aaa6-e18f-a116-e053-2991aa0a142210
995258hydrOXYzine HCl 25 MG Oral TabletPSN5bd46f87-5e1a-2d23-e053-2a91aa0a89591
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD5bd46f87-5e1a-2d23-e053-2a91aa0a89591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-217-156191902171515 TABLET in 1 BOTTLE (61919-217-15) 15 tablet2017-10-300000-00-00NoNoCurrent
61919-217-306191902173030 TABLET in 1 BOTTLE (61919-217-30) 30 tablet2017-10-300000-00-00NoNoCurrent
61919-217-606191902176060 TABLET in 1 BOTTLE (61919-217-60) 60 tablet2017-10-300000-00-00NoNoCurrent
61919-217-906191902179090 in 1 BOTTLEHistorical