Hydroxyzine pamoate

Product NDC: 0185-0676
11-digit product format: 001850676
Labeler code: 0185
Product ID: 0185-0676_c94e4245-cac4-4d59-b3a3-64a09b67c2e9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine Pamoate
Dosage form: CAPSULE
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA086183
Marketing category: ANDA
Marketing start: 1981-12-14
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0185-0676	0185-0676-10	D	Discontinued by firm		2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A086183-001	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A086183-001	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086183-001	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS, Approved before 1982	`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	A086183-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086183-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086183-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086183-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086183-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086183-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086183-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086183-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086183-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086183-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086183-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086183-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086183-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086183-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086183-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086183-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086183-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086183-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086183-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086183-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086183-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086183-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086183-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086183-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086183-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086183-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086183-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086183-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086183-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086183-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086183-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086183-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086183-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086183-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086183-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086183-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086183-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086183-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086183-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086183-001	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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
c38cfd32-2562-4d6c-8a2e-d9984c16d9eb	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
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	SPL version
0185-0676-01	Hydroxyzine pamoate	100 in 1 BOTTLE	CAPSULE	100	36
0185-0676-05	Hydroxyzine pamoate	500 in 1 BOTTLE	CAPSULE	500	36
0185-0676-10	Hydroxyzine pamoate	1000 in 1 BOTTLE	CAPSULE	1000	36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0185-0676-01	EA - Each	0185-0676	33f39b84-b055-44b5-b1ea-f77289828945	1	2021-10-08
0185-0676-05	EA - Each	0185-0676	b0c98f8a-3f44-4a6e-a145-e46e2ff479cb	1	2021-10-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXYZINE PAMOATE	ACTIVE INGREDIENT	M20215MUFR	HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]	20
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]	20
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]	20
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]	20
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]	20
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]	20
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]	20
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]	20
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]	20
GELATIN	INACTIVE INGREDIENT	2G86QN327L	HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]	20
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]	20
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]	20
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]	20
SHELLAC	INACTIVE INGREDIENT	46N107B71O	HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]	20
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]	20
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]	20
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]	20
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE PAMOATE CAPSULE [EON LABS, INC.]	20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0185-0676	HYDROXYZINE PAMOATE CAPSULE HYDROXYZINE PAMOATE CAPSULE HYDROXYZINE PAMOATE CAPSULE [SANDOZ INC]	36	Current NDC, Legacy NDC, 3 package rows	20240320_c38cfd32-2562-4d6c-8a2e-d9984c16d9eb.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine pamoate	HYDROXYZINE PAMOATE	REMEDYREPACK INC.	0c9101ee-0746-4833-83cf-d0d09e52c0a9	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086183 application number: ANDA086183
Hydroxyzine pamoate	HYDROXYZINE PAMOATE	Unit Dose Solutions, Inc.	55033469-f5c6-5180-e063-6394a90af5eb	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086183 application number: ANDA086183
Hydroxyzine pamoate	HYDROXYZINE PAMOATE	Unit Dose Solutions, Inc.	5505ef8f-0322-b705-e063-6394a90a5c5c	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086183 application number: ANDA086183
Hydroxyzine pamoate	HYDROXYZINE PAMOATE	Coupler LLC	509e9a9c-23a3-ade4-e063-6294a90a7403	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086183 application number: ANDA086183
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Direct_Rx	fcec985f-9ded-6534-e053-6294a90ac76b	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086183 application number: ANDA086183
Hydroxyzine pamoate	HYDROXYZINE PAMOATE	NuCare Pharmaceuticals,Inc.	1136a291-2f2f-c025-e063-6294a90a76d7	2024-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086183 application number: ANDA086183
Hydroxyzine pamoate	HYDROXYZINE PAMOATE	A-S Medication Solutions	dd6b78d3-6052-40d8-8dd3-d9ea2ab47c9b	2024-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086183 application number: ANDA086183
Hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	8132d8a9-4d74-4c0a-8db2-e08e34c3e7e0	2023-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086183 application number: ANDA086183
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Sandoz Inc	c38cfd32-2562-4d6c-8a2e-d9984c16d9eb	2022-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086183 application number: ANDA086183 ndc (product): 0185-0676

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
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	8132d8a9-4d74-4c0a-8db2-e08e34c3e7e0	102
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	8132d8a9-4d74-4c0a-8db2-e08e34c3e7e0	102
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	8132d8a9-4d74-4c0a-8db2-e08e34c3e7e0	102
995253	hydrOXYzine pamoate 25 MG Oral Capsule	PSN	c38cfd32-2562-4d6c-8a2e-d9984c16d9eb	36
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	c38cfd32-2562-4d6c-8a2e-d9984c16d9eb	36
995253	hydroxyzine pamoate 25 MG Oral Capsule	SCD	c38cfd32-2562-4d6c-8a2e-d9984c16d9eb	36
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	c38cfd32-2562-4d6c-8a2e-d9984c16d9eb	36
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	c38cfd32-2562-4d6c-8a2e-d9984c16d9eb	36
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	0c9101ee-0746-4833-83cf-d0d09e52c0a9	10
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	0c9101ee-0746-4833-83cf-d0d09e52c0a9	10
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	0c9101ee-0746-4833-83cf-d0d09e52c0a9	10
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	fcec985f-9ded-6534-e053-6294a90ac76b	4
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	1030e6b6-7688-4756-b54b-925801656977	4
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	fcec985f-9ded-6534-e053-6294a90ac76b	4
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	1030e6b6-7688-4756-b54b-925801656977	4
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	fcec985f-9ded-6534-e053-6294a90ac76b	4
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	1030e6b6-7688-4756-b54b-925801656977	4
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	737d39fd-4b11-4e8d-a546-ba9189fdbd9e	1
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	509e9a9c-23a3-ade4-e063-6294a90a7403	1
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	1136a291-2f2f-c025-e063-6294a90a76d7	1
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	dd6b78d3-6052-40d8-8dd3-d9ea2ab47c9b	1
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	737d39fd-4b11-4e8d-a546-ba9189fdbd9e	1
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	509e9a9c-23a3-ade4-e063-6294a90a7403	1
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	1136a291-2f2f-c025-e063-6294a90a76d7	1
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	dd6b78d3-6052-40d8-8dd3-d9ea2ab47c9b	1
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	737d39fd-4b11-4e8d-a546-ba9189fdbd9e	1
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	509e9a9c-23a3-ade4-e063-6294a90a7403	1
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	1136a291-2f2f-c025-e063-6294a90a76d7	1
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	dd6b78d3-6052-40d8-8dd3-d9ea2ab47c9b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0185-0676-01	00185067601	100 CAPSULE in 1 BOTTLE (0185-0676-01)	100 capsule	2021-09-14	0000-00-00	No	No	Current
0185-0676-05	00185067605	500 CAPSULE in 1 BOTTLE (0185-0676-05)	500 capsule	2021-09-14	0000-00-00	No	No	Current
0185-0676-10	00185067610	1000 in 1 BOTTLE						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxyzine Pamoate Capsules, USP	REMEDYREPACK INC.	2026-08-05	HUMAN PRESCRIPTION DRUG LABEL	11
Hydroxyzine Pamoate Capsules, USP	Unit Dose Solutions, Inc.	2026-06-24	HUMAN PRESCRIPTION DRUG LABEL	1
Hydroxyzine Pamoate Capsules, USP	Unit Dose Solutions, Inc.	2026-06-24	HUMAN PRESCRIPTION DRUG LABEL	1
Hydroxyzine Pamoate Capsules, USP	Coupler LLC	2026-04-29	HUMAN PRESCRIPTION DRUG LABEL	1
Hydroxyzine Pamoate	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	4
Hydroxyzine Pamoate Capsules, USP	Preferred Pharmaceuticals Inc.	2024-05-23	HUMAN PRESCRIPTION DRUG LABEL	4
Hydroxyzine Pamoate Capsules, USP	NuCare Pharmaceuticals,Inc.	2024-02-12	HUMAN PRESCRIPTION DRUG LABEL	1
Hydroxyzine Pamoate Capsules, USP	A-S Medication Solutions	2024-01-21	HUMAN PRESCRIPTION DRUG LABEL	1
Hydroxyzine Pamoate Capsules, USP	Correct Rx Pharmacy Services, Inc.	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	1
Hydroxyzine Pamoate Capsules, USP	Bryant Ranch Prepack	2023-11-27	HUMAN PRESCRIPTION DRUG LABEL	102
Hydroxyzine Pamoate Capsules, USP	Sandoz Inc	2022-06-27	HUMAN PRESCRIPTION DRUG LABEL	36
Hydroxyzine Pamoate Capsules, USP	A-S Medication Solutions	2022-03-10	HUMAN PRESCRIPTION DRUG LABEL	1