HYDROXYZINE PAMOATE

Product NDC: 64980-170
11-digit product format: 649800170
Labeler code: 64980
Product ID: 64980-170_6491d5b0-7f1b-4ac0-8791-308401000e4d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYDROXYZINE PAMOATE
Dosage form: CAPSULE
Route: ORAL
Labeler: Rising Pharmaceuticals Inc.
Application: ANDA201507
Marketing category: ANDA
Marketing start: 2010-11-17
Marketing end: 0000-00-00
Substance: HYDROXYZINE PAMOATE
Active strength: 50 mg/1
Pharmacologic classes: Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64980-170		D	Discontinued by firm	2026-08-03
excluded package	package	64980-170	64980-170-01	D	Discontinued by firm	2026-08-03
excluded package	package	64980-170	64980-170-05	D	Discontinued by firm	2026-08-03

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 2 · 63 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64980-170-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64980-170-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64980-170-05	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64980-170-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64980-170-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64980-170-05	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64980-170-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64980-170-05	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64980-170-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64980-170-05	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64980-170-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64980-170-05	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64980-170-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64980-170-05	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64980-170-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64980-170-05	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64980-170-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64980-170-05	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64980-170-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64980-170-05	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64980-170-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64980-170-05	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64980-170-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64980-170-05	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64980-170-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64980-170-05	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64980-170-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64980-170-05	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64980-170-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64980-170-05	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	64980-170-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	64980-170-05	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	64980-170-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	64980-170-05	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	64980-170-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	64980-170-05	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	64980-170-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	64980-170-05	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	64980-170-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	64980-170-05	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201507-001	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03
A201507-002	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A201507-001	AB
A201507-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB	RS	2013-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	BX		2013-06-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	BX		2013-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	BX		2013-06-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	BX		2013-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	BX		2013-06-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	BX		2013-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	AB		2013-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	BX		2013-06-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	BX		2013-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201507-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	BX		2013-06-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201507-002	HYDROXYZINE PAMOATE	EQ 50MG HYDROCHLORIDE	CAPSULE / ORAL	BX		2013-06-03	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A201507-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201507-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201507-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201507-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201507-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201507-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201507-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201507-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201507-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201507-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201507-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201507-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201507-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201507-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201507-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201507-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201507-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201507-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201507-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201507-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201507-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201507-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201507-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201507-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201507-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201507-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201507-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201507-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201507-001	BX	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201507-002	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201507-001	BX	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201507-002	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201507-001	BX	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201507-002	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201507-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201507-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201507-001	BX	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201507-002	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201507-001	BX	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201507-002	BX	1	`782e0a99824c…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
64980-170-01	2025-07-23	Hydroxyzine Pamoate Capsules, USP Rx only
64980-170-05	2025-07-23	Hydroxyzine Pamoate Capsules, USP Rx only
64980-170-01	2020-01-31	Hydroxyzine Pamoate Capsules, USP Rx only
64980-170-05	2020-01-31	Hydroxyzine Pamoate Capsules, USP Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64980-170-01	EA - Each	64980-170	4095c82e-2497-4d25-8296-054e1ef5ef4e	1	2013-11-04
64980-170-05	EA - Each	64980-170	0dcde2cd-2752-4290-ba62-29e8d48efdf6	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXYZINE PAMOATE	ACTIVE INGREDIENT	M20215MUFR	HYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]	10
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]	10
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]	10
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]	10
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]	10
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]	10
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]	10
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]	10
HYDROXYZINE PAMOATE	ACTIVE INGREDIENT	M20215MUFR	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	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 [TYA PHARMACEUTICALS]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYZINE PAMOATE CAPSULE [TYA PHARMACEUTICALS]	4
HYDROXYZINE PAMOATE	ACTIVE INGREDIENT	M20215MUFR	HYDROXYZINE PAMOATE CAPSULE [WESTWOOD MANUFACTURING]	2
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE PAMOATE CAPSULE [WESTWOOD MANUFACTURING]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROXYZINE PAMOATE CAPSULE [WESTWOOD MANUFACTURING]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROXYZINE PAMOATE CAPSULE [WESTWOOD MANUFACTURING]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HYDROXYZINE PAMOATE CAPSULE [WESTWOOD MANUFACTURING]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROXYZINE PAMOATE CAPSULE [WESTWOOD MANUFACTURING]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROXYZINE PAMOATE CAPSULE [WESTWOOD MANUFACTURING]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE PAMOATE CAPSULE [WESTWOOD MANUFACTURING]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROXYZINE PAMOATE CAPSULE [WESTWOOD MANUFACTURING]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE PAMOATE CAPSULE [WESTWOOD MANUFACTURING]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYZINE PAMOATE CAPSULE [WESTWOOD MANUFACTURING]	2
HYDROXYZINE PAMOATE	ACTIVE INGREDIENT	M20215MUFR	HYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	HYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROXYZINE PAMOATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64980-170	HYDROXYZINE PAMOATE CAPSULE [RISING PHARMACEUTICALS INC.]	11	Legacy NDC	20170411_28cf4268-b8b6-4fd5-9bc6-3d44cba6cb38.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Cardinal Health 107, LLC	6ffb7c82-f780-4527-a7c3-e7d0f7b3b91e	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Coupler LLC	5020c699-6fc5-b166-e063-6294a90a5881	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Preferred Pharmaceuticals Inc.	b903f7e1-250d-46d8-a1ec-3f1dabc597f1	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Northwind Health Company, LLC	127617c2-9775-3859-e063-6394a90a77cd	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Northwind Health Company, LLC	db8987d6-9814-50f6-e053-2a95a90a82a9	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
Hydroxyzine pamoate	HYDROXYZINE PAMOATE	Chartwell RX, LLC	abe7280a-1f6a-404b-9874-7710121e2090	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Major Pharmaceuticals	f28f2a1b-8d65-4646-bd99-6e77617f9e1f	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	7996dfa3-7f34-4d20-acaa-7f6fc021fc80	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	REMEDYREPACK INC.	c0f7f48d-e39c-4981-9c0e-5c2eccaba424	2025-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Golden State Medical Supply, Inc.	240fd428-15af-e7d0-e063-6394a90acbc5	2025-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	734d32c8-38d3-430f-a2b3-539e03a3687a	2025-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Preferred Pharmaceuticals, Inc.	2a66117a-fcd4-4094-927c-3a7699ef9660	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	A-S Medication Solutions	74bf62c3-b444-46dc-aab6-af74b101a68a	2025-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Aphena Pharma Solutions - Tennessee, LLC	308cd178-a9d2-3132-e063-6394a90a7357	2025-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Direct_Rx	8c395a13-9da3-7b77-e053-2995a90a1916	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	A-S Medication Solutions	a31271f0-ac60-4fda-b1f5-ddf7241c8a0e	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	NuCare Pharmaceuticals,Inc.	8cb94f1d-1e45-531a-e053-2a95a90a1ba0	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	dde576e9-fb6b-40d2-a81f-ebb8656c4c9c	2024-05-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	NuCare Pharmaceuticals,Inc.	1302c511-eb25-5818-e063-6394a90a9225	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Aphena Pharma Solutions - Tennessee, LLC	78005ad7-290c-4716-937f-f0ec82f4e607	2024-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201507 application number: ANDA201507

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	29130fb6-7920-4cea-af10-7d23029a7140	4
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	29130fb6-7920-4cea-af10-7d23029a7140	4
995253	hydroxyzine pamoate 25 MG Oral Capsule	SCD	29130fb6-7920-4cea-af10-7d23029a7140	4
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	29130fb6-7920-4cea-af10-7d23029a7140	4
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	29130fb6-7920-4cea-af10-7d23029a7140	4
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	a5008eba-91a4-cb2f-e053-2a95a90a869e	2
995278	hydrOXYzine pamoate 50 MG Oral Capsule	PSN	e97b2b86-bea0-4203-97c8-b27510a524a3	2
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	a5008eba-91a4-cb2f-e053-2a95a90a869e	2
995278	hydroxyzine pamoate 50 MG Oral Capsule	SCD	e97b2b86-bea0-4203-97c8-b27510a524a3	2
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	a5008eba-91a4-cb2f-e053-2a95a90a869e	2
995278	hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule	SY	e97b2b86-bea0-4203-97c8-b27510a524a3	2

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydroxyzine Pamoate Capsules, USP Rx only	Golden State Medical Supply, Inc.	2021-10-19	HUMAN PRESCRIPTION DRUG LABEL	4
Hydroxyzine Pamoate 50mg	RedPharm Drug, Inc. \| EPM Packaging	2020-05-01	HUMAN PRESCRIPTION DRUG LABEL	2
Hydroxyzine Pamoate Capsules, USP Rx only	REMEDYREPACK INC.	2019-10-30	HUMAN PRESCRIPTION DRUG LABEL	3
Hydroxyzine Pamoate Capsules, USP Rx only	Preferred Pharmaceuticals Inc.	2019-10-08	HUMAN PRESCRIPTION DRUG LABEL	2
Hydroxyzine Pamoate Capsules, USP Rx only	A-S Medication Solutions	2018-06-08	HUMAN PRESCRIPTION DRUG LABEL	1
Hydroxyzine Pamoate Capsules, USP Rx only	Rising Pharmaceuticals Inc. \| Heritage Pharma Labs, Inc	2017-04-06	HUMAN PRESCRIPTION DRUG LABEL	11
Rx only	Westwood Manufacturing	2014-08-25	Human Prescription Drug Label	2
Rx only	TYA Pharmaceuticals	2014-08-21	Human Prescription Drug Label	4