hydroxyzine pamoate

Product NDC: 0185-0615
11-digit product format: 001850615
Labeler code: 0185
Product ID: 0185-0615_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
Marketing end: 2026-05-31
Substance: HYDROXYZINE PAMOATE
Active strength: 50 mg/1
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0185-0615		D	Discontinued by firm	2026-08-07
excluded package	package	0185-0615	0185-0615-01	D	Discontinued by firm	2026-08-07
excluded package	package	0185-0615	0185-0615-05	D	Discontinued by firm	2026-08-07
excluded package	package	0185-0615	0185-0615-10	D	Discontinued by firm	2026-08-07

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…`

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
0185-0615-01	hydroxyzine pamoate	100 in 1 BOTTLE	CAPSULE	100	36
0185-0615-05	hydroxyzine pamoate	500 in 1 BOTTLE	CAPSULE	500	36
0185-0615-10	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
0185-0615-01	EA - Each	0185-0615	74b3c8f2-75f7-4c18-b380-c80aba5ccfa6	1	2012-07-24
0185-0615-05	EA - Each	0185-0615	90f2ce18-82b2-44dd-aa3e-a71b403383d2	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 [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
HYDROXYZINE PAMOATE	ACTIVE INGREDIENT	M20215MUFR	HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE PAMOATE CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
HYDROXYZINE PAMOATE	ACTIVE INGREDIENT	M20215MUFR	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
HYDROXYPROPYL CELLULOSE (TYPE E)	INACTIVE INGREDIENT	66O7AQV0RT	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE PAMOATE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	2
HYDROXYZINE PAMOATE	ACTIVE INGREDIENT	M20215MUFR	HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
HYDROXYZINE PAMOATE	ACTIVE INGREDIENT	M20215MUFR	HYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	HYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	HYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	HYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE PAMOATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE PAMOATE CAPSULE [CONTRACT PHARMACY SERVICES-PA]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0185-0615	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	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	REMEDYREPACK INC.	0c9101ee-0746-4833-83cf-d0d09e52c0a9	2026-03-30	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): 0185-0615

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
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
995253	hydrOXYzine pamoate 25 MG Oral Capsule	PSN	ba04ac99-6321-4431-97e1-e18083d7b137	3
995253	hydrOXYzine pamoate 25 MG Oral Capsule	PSN	4d226b9a-bd9b-4bc0-e054-00144ff8d46c	3
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	4d226b9a-bd9b-4bc0-e054-00144ff8d46c	3
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	ba04ac99-6321-4431-97e1-e18083d7b137	3
995253	hydroxyzine pamoate 25 MG Oral Capsule	SCD	ba04ac99-6321-4431-97e1-e18083d7b137	3
995253	hydroxyzine pamoate 25 MG Oral Capsule	SCD	4d226b9a-bd9b-4bc0-e054-00144ff8d46c	3
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	ba04ac99-6321-4431-97e1-e18083d7b137	3
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	4d226b9a-bd9b-4bc0-e054-00144ff8d46c	3
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	4d226b9a-bd9b-4bc0-e054-00144ff8d46c	3
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	ba04ac99-6321-4431-97e1-e18083d7b137	3
995253	hydrOXYzine pamoate 25 MG Oral Capsule	PSN	2bbcabc3-657f-4b2e-a473-774adfeba78e	1
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	27800e43-e196-3eed-e054-00144ff88e88	1
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	f305fb4a-f78f-49ff-b679-ebe84649f5a6	1
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	2bbcabc3-657f-4b2e-a473-774adfeba78e	1
995253	hydroxyzine pamoate 25 MG Oral Capsule	SCD	2bbcabc3-657f-4b2e-a473-774adfeba78e	1
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	2bbcabc3-657f-4b2e-a473-774adfeba78e	1
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	27800e43-e196-3eed-e054-00144ff88e88	1
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	f305fb4a-f78f-49ff-b679-ebe84649f5a6	1
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	2bbcabc3-657f-4b2e-a473-774adfeba78e	1
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	27800e43-e196-3eed-e054-00144ff88e88	1
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	f305fb4a-f78f-49ff-b679-ebe84649f5a6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0185-0615-01	00185061501	100 CAPSULE in 1 BOTTLE (0185-0615-01)	100 capsule	1981-12-14	2026-05-31	No	No	Current
0185-0615-05	00185061505	500 CAPSULE in 1 BOTTLE (0185-0615-05)	500 capsule	1981-12-14	2026-05-31	No	No	Current
0185-0615-10	00185061510	1000 in 1 BOTTLE						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HydrOXYzine Pamoate Capsules, USP	Bryant Ranch Prepack	2023-03-29	HUMAN PRESCRIPTION DRUG LABEL	5
Hydroxyzine Pamoate Capsules, USP	A-S Medication Solutions	2023-02-28	HUMAN PRESCRIPTION DRUG LABEL	16
Hydroxyzine Pamoate Capsules, USP	Sandoz Inc	2022-06-27	HUMAN PRESCRIPTION DRUG LABEL	36
HydrOXYzine Pamoate 50mg	RedPharm Drug, Inc. \| EPM Packaging	2022-01-19	HUMAN PRESCRIPTION DRUG LABEL	5
HYDROXYZINE PAMOATE	DIRECT RX	2021-06-03	HUMAN PRESCRIPTION DRUG LABEL	3
HydrOXYzine Pamoate Capsules, USP	Quality Care Products, LLC	2021-04-16	HUMAN PRESCRIPTION DRUG LABEL	2
HydrOXYzine Pamoate Capsules, USP	REMEDYREPACK INC.	2019-09-23	HUMAN PRESCRIPTION DRUG LABEL	3
HydrOXYzine Pamoate Capsules, USP	REMEDYREPACK INC.	2019-04-26	HUMAN PRESCRIPTION DRUG LABEL	3
HydrOXYzine Pamoate Capsules, USP	NuCare Pharmaceuticals, Inc.	2017-03-08	HUMAN PRESCRIPTION DRUG LABEL	1
HydrOXYzine Pamoate Capsules USP	Apotheca Inc.	2015-12-22	HUMAN PRESCRIPTION DRUG LABEL	1
Rx Only	NCS HealthCare of KY, Inc dba Vangard Labs	2014-05-27	HUMAN PRESCRIPTION DRUG LABEL	2
Hydroxyzine Pamoate Capsules USP	Aidarex Pharmaceuticals LLC	2014-01-04	HUMAN PRESCRIPTION DRUG LABEL	1
Hydroxyzine Pamoate Capsules USP	Physicians Total Care, Inc.	2013-02-25	HUMAN PRESCRIPTION DRUG LABEL	3
HydrOXYzine Pamoate Capsules, USP Rx only	Contract Pharmacy Services-PA	2010-08-17	HUMAN PRESCRIPTION DRUG LABEL	1