hydroxyzine pamoate

Product NDC: 71205-558
11-digit product format: 712050558
Labeler code: 71205
Product ID: 71205-558_bff75226-d194-4d64-bcbb-d7d79f5d230e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hydroxyzine pamoate
Dosage form: CAPSULE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA087479
Marketing category: ANDA
Marketing start: 1981-12-14
Substance: HYDROXYZINE PAMOATE
Active strength: 25 mg/1
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A087479-001	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	EQ 25MG 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
A087479-001	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	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087479-001	HYDROXYZINE PAMOATE	EQ 25MG HYDROCHLORIDE	CAPSULE / ORAL	AB	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	A087479-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087479-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087479-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087479-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087479-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087479-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087479-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087479-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087479-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087479-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087479-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087479-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087479-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087479-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087479-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087479-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087479-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087479-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087479-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087479-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087479-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087479-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087479-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087479-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087479-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087479-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087479-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087479-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087479-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087479-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087479-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087479-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087479-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087479-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087479-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087479-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087479-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087479-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087479-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087479-001	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	25 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
995253	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
bff75226-d194-4d64-bcbb-d7d79f5d230e	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
71205-558-30	hydroxyzine pamoate	30 in 1 BOTTLE	CAPSULE	30	1
71205-558-60	hydroxyzine pamoate	60 in 1 BOTTLE	CAPSULE	60	1
71205-558-90	hydroxyzine pamoate	90 in 1 BOTTLE	CAPSULE	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-558-30	EA - Each	71205-558	cf8a605a-90a0-4f4e-b0f5-675508badc23	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-558	HYDROXYZINE PAMOATE CAPSULE [PROFICIENT RX LP]	1	Current NDC, Legacy NDC, 3 package rows	20210520_bff75226-d194-4d64-bcbb-d7d79f5d230e.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 · 22 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.	561d8abe-97e8-5dc7-e063-6294a90a3923	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	REMEDYREPACK INC.	6432d1aa-1e73-469e-835b-43d518963f71	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	REMEDYREPACK INC.	2e59dc14-7e17-4663-bc1f-7ee8e104dbfa	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Unit Dose Solutions, Inc.	55012f2c-fa10-2a31-e063-6294a90ae718	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Coupler LLC	545f0e87-2688-5381-e063-6394a90a72d4	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	PD-Rx Pharmaceuticals, Inc.	98a1c161-5728-4626-a6b0-5414935e4eef	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Direct_Rx	8a7084e0-530c-607b-e053-2a95a90a229c	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Northwind Health Company, LLC	f99da162-f224-1c19-e053-6294a90acffb	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	PD-Rx Pharmaceuticals, Inc.	53153595-41b9-4b2d-8b7d-0ffd29fdd1d8	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	836ec7f1-e739-4b85-bb52-08d5c5ed4c11	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	2a869704-2ad0-4ef6-89e6-0f84c39542b6	2025-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Preferred Pharmaceuticals Inc.	54af47cd-65c2-4bc9-95cd-7883e56ed035	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	NuCare Pharmaceuticals,Inc.	aee7c4a8-10cb-2107-e053-2995a90a90e7	2025-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	34f7e401-9b2c-7d63-e063-6394a90a1f00	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	f74e4b3e-992c-402d-92b8-258fccb42b64	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	02616eee-a1a4-4afc-b84e-69fd28755138	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	NuCare Pharmaceutcals, Inc.	2879c79f-bf2f-0bc9-e063-6394a90a98ae	2024-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Bryant Ranch Prepack	fac2df9d-d395-4b07-b299-2ed946441b22	2024-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Pharmasource Meds, LLC	f563aa1a-1e21-49d4-e053-2a95a90a3264	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479
hydroxyzine pamoate	HYDROXYZINE PAMOATE	Aphena Pharma Solutions - Tennessee, LLC	c29f005e-ae75-415d-9fd6-591f074dcda5	2023-11-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087479 application number: ANDA087479

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	bff75226-d194-4d64-bcbb-d7d79f5d230e	1
995253	hydroxyzine pamoate 25 MG Oral Capsule	SCD	bff75226-d194-4d64-bcbb-d7d79f5d230e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-558-30	71205055830	30 CAPSULE in 1 BOTTLE (71205-558-30)	30 capsule	2021-05-03	0000-00-00	No	No	Current
71205-558-60	71205055860	60 CAPSULE in 1 BOTTLE (71205-558-60)	60 capsule	2021-05-03	0000-00-00	No	No	Current
71205-558-90	71205055890	90 CAPSULE in 1 BOTTLE (71205-558-90)	90 capsule	2021-05-03	0000-00-00	No	No	Current