Hydroxyzine Hydrochloride

Product NDC
10702-011
11-digit product format
107020011
Labeler code
10702
Product ID
10702-011_eff46bea-a884-5878-e053-2a95a90ae664
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
KVK-Tech, Inc.
Application
ANDA040786
Marketing category
ANDA
Marketing start
2012-07-24
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage10702-011-50
excluded packagepackage10702-011-10
excluded packagepackage10702-011-01

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040786-001HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-20
A040786-002HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-20
A040786-003HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A040786-001AB
A040786-002AB
A040786-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040786-002HYDROXYZINE HYDROCHLORIDE25MGTABLET / ORALAB2007-03-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040786-003HYDROXYZINE HYDROCHLORIDE50MGTABLET / ORALAB2007-03-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040786-001HYDROXYZINE HYDROCHLORIDE10MGTABLET / ORALAB2007-03-208072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040786-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040786-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040786-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040786-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040786-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040786-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040786-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040786-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040786-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040786-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040786-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040786-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040786-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040786-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040786-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040786-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040786-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040786-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040786-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040786-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040786-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040786-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040786-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040786-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040786-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040786-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040786-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040786-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040786-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040786-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040786-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040786-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040786-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040786-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040786-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040786-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040786-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040786-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040786-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040786-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxyzine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE DIHYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
76755771U3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995218Internal RxNorm lookup
995258Internal RxNorm lookup
995281Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
adc4cb73-77c6-48ff-aaf2-b3568d53de1fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57311cfb-679a-da1a-b70c-8757f7fc431aProduct name420250516
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
aa1826f4-97c1-4705-bdf0-3bc7d234e618Product name220190618
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
75cb12ee-8eb2-4f1a-a332-5743a5d0da41Product name120151110
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
3ca5f78b-43dc-30fe-8014-55b922af52b3Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10702-011-01Hydroxyzine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10012
10702-011-10Hydroxyzine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100012
10702-011-50Hydroxyzine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-011-01EA - Each10702-011e6d6cb12-dfb4-4dcb-b117-fafbc71634ce12013-02-13
10702-011-10EA - Each10702-01127da82a3-32be-4b83-b344-30718996e2c512013-02-13
10702-011-50EA - Each10702-011f0ccc126-082a-470e-8341-bb0bc392f97812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RHYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PHYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
TALCINACTIVE INGREDIENT7SEV7J4R1UHYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PHYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
TALCINACTIVE INGREDIENT7SEV7J4R1UHYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
TALCINACTIVE INGREDIENT7SEV7J4R1UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE (HYDROXYZINE HYDROCHLORIDE) TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]2
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
HYDROXYZINE HYDROCHLORIDEACTIVE INGREDIENT76755771U3HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIFE LINE HOME CARE SERVICES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-011HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [KVK-TECH, INC.]12Current NDC, Legacy NDC, 3 package rows20230126_adc4cb73-77c6-48ff-aaf2-b3568d53de1f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.4789b7ae-314c-43c0-ad33-92ff50085f272025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040786
application number: ANDA040786
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1a3e389f-391d-4f37-9e34-ce3c6f5fe8c12025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040786
application number: ANDA040786
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.cc6a12ed-411b-4b0c-8108-58ef7db8da552025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040786
application number: ANDA040786
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEBryant Ranch Prepack3f5be725-8ade-4889-b6b1-7d45f54585462024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040786
application number: ANDA040786
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEKVK-Tech, Inc.adc4cb73-77c6-48ff-aaf2-b3568d53de1f2023-01-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040786
application number: ANDA040786
ndc (product): 10702-011

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995258hydrOXYzine HCl 25 MG Oral TabletPSN24cb9c83-a7e4-4bae-997c-c3a87426f78c23
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD24cb9c83-a7e4-4bae-997c-c3a87426f78c23
995218hydrOXYzine HCl 10 MG Oral TabletPSN1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122
995258hydrOXYzine HCl 25 MG Oral TabletPSN1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122
995281hydrOXYzine HCl 50 MG Oral TabletPSN1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122
995258hydrOXYzine HCl 25 MG Oral TabletPSNcc6a12ed-411b-4b0c-8108-58ef7db8da5516
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDcc6a12ed-411b-4b0c-8108-58ef7db8da5516
995258hydrOXYzine HCl 25 MG Oral TabletPSNaa9523e0-c95d-4213-b213-96170d85553614
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDaa9523e0-c95d-4213-b213-96170d85553614
995218hydrOXYzine HCl 10 MG Oral TabletPSNadc4cb73-77c6-48ff-aaf2-b3568d53de1f12
995258hydrOXYzine HCl 25 MG Oral TabletPSNadc4cb73-77c6-48ff-aaf2-b3568d53de1f12
995281hydrOXYzine HCl 50 MG Oral TabletPSNadc4cb73-77c6-48ff-aaf2-b3568d53de1f12
995218hydroxyzine hydrochloride 10 MG Oral TabletSCDadc4cb73-77c6-48ff-aaf2-b3568d53de1f12
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDadc4cb73-77c6-48ff-aaf2-b3568d53de1f12
995281hydroxyzine hydrochloride 50 MG Oral TabletSCDadc4cb73-77c6-48ff-aaf2-b3568d53de1f12
995258hydrOXYzine HCl 25 MG Oral TabletPSN78eaf4fd-26c7-83bc-e053-2a91aa0a94d32
995258hydrOXYzine HCl 25 MG Oral TabletPSN888e3d6c-a2e4-11e3-e053-2a95a90af2792
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD78eaf4fd-26c7-83bc-e053-2a91aa0a94d32
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD888e3d6c-a2e4-11e3-e053-2a95a90af2792
995258hydrOXYzine HCl 25 MG Oral TabletPSN308252c8-08ef-4864-846b-fbcae823141f1
995258hydrOXYzine HCl 25 MG Oral TabletPSNbeefb4ba-ee88-4923-96b0-72050466847b1
995258hydrOXYzine HCl 25 MG Oral TabletPSN3f5be725-8ade-4889-b6b1-7d45f54585461
995258hydroxyzine hydrochloride 25 MG Oral TabletSCDbeefb4ba-ee88-4923-96b0-72050466847b1
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD308252c8-08ef-4864-846b-fbcae823141f1
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD3f5be725-8ade-4889-b6b1-7d45f54585461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10702-011-0110702001101100 TABLET, FILM COATED in 1 BOTTLE (10702-011-01) 2012-07-240000-00-00NoNoCurrent
10702-011-10107020011101000 TABLET, FILM COATED in 1 BOTTLE (10702-011-10) 2012-07-240000-00-00NoNoCurrent
10702-011-5010702001150500 TABLET, FILM COATED in 1 BOTTLE (10702-011-50) 2012-07-240000-00-00NoNoCurrent