Hydroxyzine Pamoate

Product NDC: 0555-0302
11-digit product format: 005550302
Labeler code: 0555
Product ID: 0555-0302_c307ca43-d41f-401b-bd15-0c753eca86e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine Pamoate
Dosage form: CAPSULE
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA088487
Marketing category: ANDA
Marketing start: 1984-07-01
Substance: HYDROXYZINE PAMOATE
Active strength: 50 mg/1
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088487-001	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB		1984-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A088487-001	AB

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088487-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	1984-06-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A088487-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088487-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088487-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088487-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088487-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088487-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088487-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088487-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088487-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088487-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088487-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088487-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088487-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088487-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088487-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088487-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088487-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088487-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088487-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088487-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088487-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088487-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088487-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088487-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088487-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088487-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088487-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088487-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088487-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088487-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088487-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088487-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088487-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088487-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088487-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088487-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088487-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088487-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088487-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088487-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROXYZINE PAMOATE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
M20215MUFR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
995232	Internal RxNorm lookup
995253	Internal RxNorm lookup
995278	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
06068fff-2e79-4721-bcc7-b0938aa20e7a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
57311cfb-679a-da1a-b70c-8757f7fc431a	Product name	4	20250516
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
aa1826f4-97c1-4705-bdf0-3bc7d234e618	Product name	2	20190618
75cb12ee-8eb2-4f1a-a332-5743a5d0da41	Product name	1	20151110
3ca5f78b-43dc-30fe-8014-55b922af52b3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0555-0302-02	Hydroxyzine Pamoate	100 in 1 BOTTLE	CAPSULE	100		20
0555-0302-04	Hydroxyzine Pamoate	500 in 1 BOTTLE	CAPSULE	500		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0555-0302-02	EA - Each	0555-0302	8cc3894c-2f58-4823-b013-a288bd9aaf30	1	2012-07-24
0555-0302-04	EA - Each	0555-0302	2f8d99d9-2d70-4535-9893-587574b56dcf	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXYZINE PAMOATE	ACTIVE INGREDIENT	M20215MUFR	HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]	9
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]	9
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]	9
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]	9
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]	9
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]	9
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]	9
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]	9
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]	9
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]	9
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]	9
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]	9
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]	9
GELATIN	INACTIVE INGREDIENT	2G86QN327L	HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]	9
INDIGOTINDISULFONATE SODIUM	INACTIVE INGREDIENT	D3741U8K7L	HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]	9
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]	9
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]	9
SHELLAC	INACTIVE INGREDIENT	46N107B71O	HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE PAMOATE CAPSULE [BARR LABORATORIES INC.]	9
HYDROXYZINE PAMOATE	ACTIVE INGREDIENT	M20215MUFR	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
HYDROXYZINE PAMOATE	ACTIVE INGREDIENT	M20215MUFR	HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
INDIGOTINDISULFONATE SODIUM	INACTIVE INGREDIENT	D3741U8K7L	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
INDIGOTINDISULFONATE SODIUM	INACTIVE INGREDIENT	D3741U8K7L	HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
HYDROXYZINE PAMOATE	ACTIVE INGREDIENT	M20215MUFR	HYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	HYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYZINE PAMOATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0555-0302	HYDROXYZINE PAMOATE CAPSULE [TEVA PHARMACEUTICALS USA, INC.]	18	Current NDC, Legacy NDC, 2 package rows	20221020_06068fff-2e79-4721-bcc7-b0938aa20e7a.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Northwind Health Company, LLC	faf7932b-40ee-8822-e053-6394a90a5e40	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088487 application number: ANDA088487
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Asclemed USA, Inc.	82187031-779e-47bc-943c-eb1a1ef30a7a	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088487 application number: ANDA088487
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	American Health Packaging	e1a7d95c-e6f6-4a89-90b0-002156e90b41	2024-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088487 application number: ANDA088487
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Teva Pharmaceuticals USA, Inc.	06068fff-2e79-4721-bcc7-b0938aa20e7a	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088487 application number: ANDA088487 ndc (product): 0555-0302

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M20215MUFR	HYDROXYZINE PAMOATE	10246-75-0	HYDROXYZINE PAMOATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995232	hydrOXYzine pamoate 100 MG Oral Capsule	PSN	06068fff-2e79-4721-bcc7-b0938aa20e7a	20
995253	hydrOXYzine pamoate 25 MG Oral Capsule	PSN	06068fff-2e79-4721-bcc7-b0938aa20e7a	20
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	06068fff-2e79-4721-bcc7-b0938aa20e7a	20
995232	hydroxyzine pamoate 100 MG Oral Capsule	SCD	06068fff-2e79-4721-bcc7-b0938aa20e7a	20
995253	hydroxyzine pamoate 25 MG Oral Capsule	SCD	06068fff-2e79-4721-bcc7-b0938aa20e7a	20
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	06068fff-2e79-4721-bcc7-b0938aa20e7a	20
995232	hydroxyzine hydrochloride 100 MG (hydroxyzine pamoate 170.4 MG) Oral Capsule	SY	06068fff-2e79-4721-bcc7-b0938aa20e7a	20
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	06068fff-2e79-4721-bcc7-b0938aa20e7a	20
995253	hydrOXYzine pamoate 25 MG Oral Capsule	PSN	e1a7d95c-e6f6-4a89-90b0-002156e90b41	5
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	e1a7d95c-e6f6-4a89-90b0-002156e90b41	5
995253	hydroxyzine pamoate 25 MG Oral Capsule	SCD	e1a7d95c-e6f6-4a89-90b0-002156e90b41	5
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	e1a7d95c-e6f6-4a89-90b0-002156e90b41	5
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	e1a7d95c-e6f6-4a89-90b0-002156e90b41	5
995253	hydrOXYzine pamoate 25 MG Oral Capsule	PSN	1094b1ca-bb30-435c-8b2a-27d9fc79f119	4
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	1094b1ca-bb30-435c-8b2a-27d9fc79f119	4
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	0fa8b4a6-76d6-440b-97b6-e67df490881f	4
995253	hydroxyzine pamoate 25 MG Oral Capsule	SCD	1094b1ca-bb30-435c-8b2a-27d9fc79f119	4
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	1094b1ca-bb30-435c-8b2a-27d9fc79f119	4
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	0fa8b4a6-76d6-440b-97b6-e67df490881f	4
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	1094b1ca-bb30-435c-8b2a-27d9fc79f119	4
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	0fa8b4a6-76d6-440b-97b6-e67df490881f	4
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	b450ec67-4217-4627-9265-0a416f6c7e28	3
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	b450ec67-4217-4627-9265-0a416f6c7e28	3
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	b450ec67-4217-4627-9265-0a416f6c7e28	3
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	faf7932b-40ee-8822-e053-6394a90a5e40	2
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	faf7932b-40ee-8822-e053-6394a90a5e40	2
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	faf7932b-40ee-8822-e053-6394a90a5e40	2
995232	hydrOXYzine pamoate 100 MG Oral Capsule	PSN	b1836032-29b4-43ae-a110-14ac2f9f1d3e	1
995232	hydrOXYzine pamoate 100 MG Oral Capsule	PSN	82187031-779e-47bc-943c-eb1a1ef30a7a	1
995253	hydrOXYzine pamoate 25 MG Oral Capsule	PSN	b1836032-29b4-43ae-a110-14ac2f9f1d3e	1
995253	hydrOXYzine pamoate 25 MG Oral Capsule	PSN	82187031-779e-47bc-943c-eb1a1ef30a7a	1
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	ddc140c6-9919-4d69-a201-50f2308e147f	1
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	82187031-779e-47bc-943c-eb1a1ef30a7a	1
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	b1836032-29b4-43ae-a110-14ac2f9f1d3e	1
995232	hydroxyzine pamoate 100 MG Oral Capsule	SCD	b1836032-29b4-43ae-a110-14ac2f9f1d3e	1
995232	hydroxyzine pamoate 100 MG Oral Capsule	SCD	82187031-779e-47bc-943c-eb1a1ef30a7a	1
995253	hydroxyzine pamoate 25 MG Oral Capsule	SCD	82187031-779e-47bc-943c-eb1a1ef30a7a	1
995253	hydroxyzine pamoate 25 MG Oral Capsule	SCD	b1836032-29b4-43ae-a110-14ac2f9f1d3e	1
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	ddc140c6-9919-4d69-a201-50f2308e147f	1
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	82187031-779e-47bc-943c-eb1a1ef30a7a	1
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	b1836032-29b4-43ae-a110-14ac2f9f1d3e	1
995232	hydroxyzine hydrochloride 100 MG (hydroxyzine pamoate 170.4 MG) Oral Capsule	SY	b1836032-29b4-43ae-a110-14ac2f9f1d3e	1
995232	hydroxyzine hydrochloride 100 MG (hydroxyzine pamoate 170.4 MG) Oral Capsule	SY	82187031-779e-47bc-943c-eb1a1ef30a7a	1
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	ddc140c6-9919-4d69-a201-50f2308e147f	1
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	b1836032-29b4-43ae-a110-14ac2f9f1d3e	1
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	82187031-779e-47bc-943c-eb1a1ef30a7a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0555-0302-02	00555030202	100 CAPSULE in 1 BOTTLE (0555-0302-02)	100 capsule	1984-07-01	0000-00-00	No	No	Current
0555-0302-04	00555030204	500 CAPSULE in 1 BOTTLE (0555-0302-04)	500 capsule	1984-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HydrOXYzine Pamoate Capsules, USP	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	2
HydrOXYzine Pamoate Capsules, USP	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-02-17	HUMAN PRESCRIPTION DRUG LABEL	1
HydrOXYzine Pamoate Capsules, USP 8469601/1023 Rx only	American Health Packaging	2024-11-21	HUMAN PRESCRIPTION DRUG LABEL	5
HydrOXYzine Pamoate Capsules, USP	REMEDYREPACK INC.	2024-10-01	HUMAN PRESCRIPTION DRUG LABEL	7
HydrOXYzine Pamoate Capsules, USP	Teva Pharmaceuticals USA, Inc.	2022-10-01	HUMAN PRESCRIPTION DRUG LABEL	20
HydrOXYzine Pamoate Capsules USP	Mylan Institutional Inc.	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL	10
HydrOXYzine Pamoate Capsules USP	A-S Medication Solutions	2019-04-30	HUMAN PRESCRIPTION DRUG LABEL	4
HydrOXYzine Pamoate Capsules USP	A-S Medication Solutions	2019-04-25	HUMAN PRESCRIPTION DRUG LABEL	3
HydrOXYzine Pamoate Capsules USP	A-S Medication Solutions	2018-12-18	HUMAN PRESCRIPTION DRUG LABEL	1
HYDROXYZINE PAMOATE CAPSULES USP	TYA Pharmaceuticals	2014-08-06	HUMAN PRESCRIPTION DRUG LABEL	4
HYDROXYZINE PAMOATE CAPSULES, USP	State of Florida DOH Central Pharmacy	2010-05-25	HUMAN PRESCRIPTION DRUG LABEL	1