Application 086183

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	CAPSULE;ORAL	EQ 50MG HYDROCHLORIDE	No	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
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…`

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 ndc (product): 70518-3232
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 ndc (product): 71335-2076
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 ndc (product): 0185-0676

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-0615	hydroxyzine pamoate	hydroxyzine pamoate	Eon Labs, Inc.	ANDA	Current
0185-0615	hydroxyzine pamoate	hydroxyzine pamoate	Eon Labs, Inc.	ANDA	Current
0185-0615	hydroxyzine pamoate	hydroxyzine pamoate	Eon Labs, Inc.	ANDA	Current
0185-0615	hydroxyzine pamoate	hydroxyzine pamoate	Eon Labs, Inc.	ANDA	Current
0185-0615	hydroxyzine pamoate	hydroxyzine pamoate	Eon Labs, Inc.	ANDA	Current
0185-0615	hydroxyzine pamoate	hydroxyzine pamoate	Eon Labs, Inc.	ANDA	Current
0185-0676	Hydroxyzine pamoate	Hydroxyzine Pamoate	Eon Labs, Inc.	ANDA	Current
0185-0676	Hydroxyzine pamoate	Hydroxyzine Pamoate	Eon Labs, Inc.	ANDA	Current
0185-0676	Hydroxyzine pamoate	Hydroxyzine Pamoate	Eon Labs, Inc.	ANDA	Current
0185-0676	Hydroxyzine pamoate	Hydroxyzine Pamoate	Eon Labs, Inc.	ANDA	Current
0615-0332	Hydroxyzine Pamoate	Hydroxyzine Pamoate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
12634-833	hydroxyzine pamoate	hydroxyzine pamoate	Apotheca Inc.	ANDA	Current
33261-858	hydroxyzine pamoate	hydroxyzine pamoate	Aidarex Pharmaceuticals LLC	ANDA	Current
50090-0374	hydroxyzine pamoate	hydroxyzine pamoate	A-S Medication Solutions	ANDA	Current
50090-2664	hydroxyzine pamoate	hydroxyzine pamoate	A-S Medication Solutions	ANDA	Current
50090-5934	Hydroxyzine pamoate	Hydroxyzine Pamoate	A-S Medication Solutions	ANDA	Current
55700-742	hydroxyzine pamoate	hydroxyzine pamoate	Quality Care Products, LLC	ANDA	Current
55700-742	hydroxyzine pamoate	hydroxyzine pamoate	Quality Care Products, LLC	ANDA	Current
61919-647	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	DIRECT RX	ANDA	Current
61919-647	HYDROXYZINE PAMOATE	HYDROXYZINE PAMOATE	DIRECT RX	ANDA	Current
62584-741	Hydroxyzine Pamoate	Hydroxyzine Pamoate	American Health Packaging	ANDA	Current
67046-282	Hydroxyzine Pamoate	HYDROXYZINE PAMOATE	Contract Pharmacy Services-PA	ANDA	Current
67296-0222	hydroxyzine pamoate	hydroxyzine pamoate	RedPharm Drug, Inc.	ANDA	Current
67296-0222	hydroxyzine pamoate	hydroxyzine pamoate	RedPharm Drug, Inc.	ANDA	Current
68071-3158	hydroxyzine pamoate	hydroxyzine pamoate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-0523	hydroxyzine pamoate	hydroxyzine pamoate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-8111	Hydroxyzine pamoate	Hydroxyzine Pamoate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8111	Hydroxyzine pamoate	Hydroxyzine Pamoate	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-1471	hydroxyzine pamoate	hydroxyzine pamoate	REMEDYREPACK INC.	ANDA	Current
70518-1471	hydroxyzine pamoate	hydroxyzine pamoate	REMEDYREPACK INC.	ANDA	Current
70518-1659	hydroxyzine pamoate	hydroxyzine pamoate	REMEDYREPACK INC.	ANDA	Current
70518-1659	hydroxyzine pamoate	hydroxyzine pamoate	REMEDYREPACK INC.	ANDA	Current
70518-3232	Hydroxyzine pamoate	Hydroxyzine Pamoate	REMEDYREPACK INC.	ANDA	Current
70518-3232	Hydroxyzine pamoate	Hydroxyzine Pamoate	REMEDYREPACK INC.	ANDA	Current
71335-1058	hydroxyzine pamoate	hydroxyzine pamoate	Bryant Ranch Prepack	ANDA	Current
71335-1058	hydroxyzine pamoate	hydroxyzine pamoate	Bryant Ranch Prepack	ANDA	Current
71335-1058	hydroxyzine pamoate	hydroxyzine pamoate	Bryant Ranch Prepack	ANDA	Current
71335-2076	Hydroxyzine pamoate	Hydroxyzine Pamoate	Bryant Ranch Prepack	ANDA	Current