Hydrochlorothiazide

Product NDC: 50228-146
11-digit product format: 502280146
Labeler code: 50228
Product ID: 50228-146_6847f060-0180-4f7e-aba8-4dce8c53e7ae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrochlorothiazide
Dosage form: CAPSULE
Route: ORAL
Labeler: ScieGen Pharmaceuticals Inc
Application: ANDA203561
Marketing category: ANDA
Marketing start: 2019-01-14
Substance: HYDROCHLOROTHIAZIDE
Active strength: 12.5 mg/1
Pharmacologic classes: Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A203561-001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB		2019-01-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203561-001	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2019-01-14	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203561-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203561-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203561-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203561-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203561-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203561-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203561-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203561-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203561-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203561-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203561-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203561-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203561-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203561-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203561-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203561-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203561-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203561-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203561-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203561-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203561-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203561-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203561-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203561-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203561-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203561-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203561-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203561-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203561-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203561-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203561-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203561-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203561-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203561-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203561-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203561-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203561-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203561-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203561-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203561-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydrochlorothiazide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCHLOROTHIAZIDE	12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0J48LPH2TH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199903	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
911a18c1-120a-46b3-b7a8-25eb37843473	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
1199f4b7-b537-466c-9a1c-cb09131e9f8b	Product name	1	20251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6f	Product name	3	20251027
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
8b67f333-47d1-8464-7ce4-406d3dbb295f	Product name	7	20190618
89a57420-ab44-5323-14f9-595159145f9b	Product name	2	20190612
c27b049d-3258-48cf-ebe5-08c236ae78e2	Product name	3	20190610
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
00fc2cf9-672f-3e0b-6afa-43cbc864d058	Product name	4	20180613
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108
a7349398-661d-d9fc-46df-7e128bbd61d9	Product name	5	20171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
ea069444-e874-4c28-833f-d2f52734ef4d	Product name	1	20150206
041df61b-f8b6-48a6-7b67-411e1412678b	Product name	1	20140508
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508
433a3439-b8f3-d13a-d2c8-9b221d628d60	Product name	1	20140508
59212689-39e5-a976-6d21-882d76d8079a	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
78637fb0-95c8-441f-e4b4-db1274b6f956	Product name	1	20140508
df89bd47-2db4-d593-ab37-d11953fd5536	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50228-146-01	Hydrochlorothiazide	100 in 1 BOTTLE	CAPSULE	100	6
50228-146-05	Hydrochlorothiazide	500 in 1 BOTTLE	CAPSULE	500	6
50228-146-10	Hydrochlorothiazide	1000 in 1 BOTTLE	CAPSULE	1000	6
50228-146-30	Hydrochlorothiazide	30 in 1 BOTTLE	CAPSULE	30	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50228-146-01	EA - Each	50228-146	a4d9dda4-60a9-489e-838a-d852c057a2aa	1	2019-04-11
50228-146-05	EA - Each	50228-146	b8192689-b5bc-4e0a-ada1-73b429b47f0f	1	2019-04-11
50228-146-10	EA - Each	50228-146	6b72885e-429f-4161-a323-599692e5a2fa	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50228-146	HYDROCHLOROTHIAZIDE CAPSULE [SCIEGEN PHARMACEUTICALS INC]	5	Current NDC, Legacy NDC, 4 package rows	20241109_911a18c1-120a-46b3-b7a8-25eb37843473.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	0789baef-3424-43ab-a3fb-4908172da565	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	cb7b7315-0170-492c-803f-60a6e75e55da	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	2b21f3fc-4164-401a-803e-b982dea97e19	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals, Inc.	918391e3-e8b3-4ceb-b4e7-c7c9617ea882	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	ff557069-f177-4e2e-91f4-675a033e2739	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	45316037-52ec-438f-8780-b2e983fef3f5	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Westminster Pharmaceuticals, LLC	0fc94bc2-fa38-439a-a609-1b4130cdacb1	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	ScieGen Pharmaceuticals Inc	911a18c1-120a-46b3-b7a8-25eb37843473	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561 ndc (product): 50228-146
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	AvPAK	ef56450d-86d3-2654-e053-2995a90a142c	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f32ce8fe-6cbc-8a15-e053-2995a90a8eec	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	02a481cb-ad80-41bb-82d3-c237b00ed8d7	2025-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	bd5728a2-6322-42e3-bd1e-e4915750e398	2023-12-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	NCS HealthCare of KY, LLC dba Vangard Labs	d6b933c6-f5f8-406a-84d6-b22c6040482a	2023-10-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	460f922c-1fda-44a5-889e-d7009883176b	2023-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Aphena Pharma Solutions - Tennessee, LLC	69c41abb-75f4-429b-905a-1ce967924aee	2023-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	b54ec2b1-3325-46a1-b654-8a75dc41ab0a	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Aphena Pharma Solutions - Tennessee, LLC	f0b993f2-9771-42e3-b10e-09719189e2bd	2021-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199903	hydroCHLOROthiazide 12.5 MG Oral Capsule	PSN	2b21f3fc-4164-401a-803e-b982dea97e19	106
199903	hydrochlorothiazide 12.5 MG Oral Capsule	SCD	2b21f3fc-4164-401a-803e-b982dea97e19	106
199903	HCTZ 12.5 MG Oral Capsule	SY	2b21f3fc-4164-401a-803e-b982dea97e19	106
199903	hydroCHLOROthiazide 12.5 MG Oral Capsule	PSN	ff557069-f177-4e2e-91f4-675a033e2739	103
199903	hydrochlorothiazide 12.5 MG Oral Capsule	SCD	ff557069-f177-4e2e-91f4-675a033e2739	103
199903	HCTZ 12.5 MG Oral Capsule	SY	ff557069-f177-4e2e-91f4-675a033e2739	103
199903	hydroCHLOROthiazide 12.5 MG Oral Capsule	PSN	45316037-52ec-438f-8780-b2e983fef3f5	101
199903	hydrochlorothiazide 12.5 MG Oral Capsule	SCD	45316037-52ec-438f-8780-b2e983fef3f5	101
199903	HCTZ 12.5 MG Oral Capsule	SY	45316037-52ec-438f-8780-b2e983fef3f5	101
199903	hydroCHLOROthiazide 12.5 MG Oral Capsule	PSN	0789baef-3424-43ab-a3fb-4908172da565	13
199903	hydrochlorothiazide 12.5 MG Oral Capsule	SCD	0789baef-3424-43ab-a3fb-4908172da565	13
199903	HCTZ 12.5 MG Oral Capsule	SY	0789baef-3424-43ab-a3fb-4908172da565	13
199903	hydroCHLOROthiazide 12.5 MG Oral Capsule	PSN	cb7b7315-0170-492c-803f-60a6e75e55da	11
199903	hydrochlorothiazide 12.5 MG Oral Capsule	SCD	cb7b7315-0170-492c-803f-60a6e75e55da	11
199903	HCTZ 12.5 MG Oral Capsule	SY	cb7b7315-0170-492c-803f-60a6e75e55da	11
199903	hydroCHLOROthiazide 12.5 MG Oral Capsule	PSN	918391e3-e8b3-4ceb-b4e7-c7c9617ea882	7
199903	hydrochlorothiazide 12.5 MG Oral Capsule	SCD	918391e3-e8b3-4ceb-b4e7-c7c9617ea882	7
199903	HCTZ 12.5 MG Oral Capsule	SY	918391e3-e8b3-4ceb-b4e7-c7c9617ea882	7
199903	hydroCHLOROthiazide 12.5 MG Oral Capsule	PSN	02a481cb-ad80-41bb-82d3-c237b00ed8d7	6
199903	hydroCHLOROthiazide 12.5 MG Oral Capsule	PSN	d6b933c6-f5f8-406a-84d6-b22c6040482a	6
199903	hydroCHLOROthiazide 12.5 MG Oral Capsule	PSN	911a18c1-120a-46b3-b7a8-25eb37843473	6
199903	hydrochlorothiazide 12.5 MG Oral Capsule	SCD	911a18c1-120a-46b3-b7a8-25eb37843473	6
199903	hydrochlorothiazide 12.5 MG Oral Capsule	SCD	02a481cb-ad80-41bb-82d3-c237b00ed8d7	6
199903	hydrochlorothiazide 12.5 MG Oral Capsule	SCD	d6b933c6-f5f8-406a-84d6-b22c6040482a	6
199903	HCTZ 12.5 MG Oral Capsule	SY	02a481cb-ad80-41bb-82d3-c237b00ed8d7	6
199903	HCTZ 12.5 MG Oral Capsule	SY	911a18c1-120a-46b3-b7a8-25eb37843473	6
199903	HCTZ 12.5 MG Oral Capsule	SY	d6b933c6-f5f8-406a-84d6-b22c6040482a	6
199903	hydroCHLOROthiazide 12.5 MG Oral Capsule	PSN	f32ce8fe-6cbc-8a15-e053-2995a90a8eec	4
199903	hydrochlorothiazide 12.5 MG Oral Capsule	SCD	f32ce8fe-6cbc-8a15-e053-2995a90a8eec	4
199903	HCTZ 12.5 MG Oral Capsule	SY	f32ce8fe-6cbc-8a15-e053-2995a90a8eec	4
199903	hydroCHLOROthiazide 12.5 MG Oral Capsule	PSN	69c41abb-75f4-429b-905a-1ce967924aee	1
199903	hydroCHLOROthiazide 12.5 MG Oral Capsule	PSN	d9e27999-4ab8-7463-e053-2995a90a1dc4	1
199903	hydroCHLOROthiazide 12.5 MG Oral Capsule	PSN	bd5728a2-6322-42e3-bd1e-e4915750e398	1
199903	hydrochlorothiazide 12.5 MG Oral Capsule	SCD	d9e27999-4ab8-7463-e053-2995a90a1dc4	1
199903	hydrochlorothiazide 12.5 MG Oral Capsule	SCD	69c41abb-75f4-429b-905a-1ce967924aee	1
199903	hydrochlorothiazide 12.5 MG Oral Capsule	SCD	bd5728a2-6322-42e3-bd1e-e4915750e398	1
199903	HCTZ 12.5 MG Oral Capsule	SY	69c41abb-75f4-429b-905a-1ce967924aee	1
199903	HCTZ 12.5 MG Oral Capsule	SY	bd5728a2-6322-42e3-bd1e-e4915750e398	1
199903	HCTZ 12.5 MG Oral Capsule	SY	d9e27999-4ab8-7463-e053-2995a90a1dc4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50228-146-01	50228014601	100 CAPSULE in 1 BOTTLE (50228-146-01)	100 capsule	2019-01-14	0000-00-00	No	No	Current
50228-146-05	50228014605	500 CAPSULE in 1 BOTTLE (50228-146-05)	500 capsule	2019-01-14	0000-00-00	No	No	Current
50228-146-10	50228014610	1000 CAPSULE in 1 BOTTLE (50228-146-10)	1000 capsule	2019-01-14	0000-00-00	No	No	Current
50228-146-30	50228014630	30 CAPSULE in 1 BOTTLE (50228-146-30)	30 capsule	2019-01-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrochlorothiazide - REMEDYREPACK INC.	REMEDYREPACK INC.	2026-07-24	HUMAN PRESCRIPTION DRUG LABEL	14
Hydrochlorothiazide - PD-Rx Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	2026-07-08	HUMAN PRESCRIPTION DRUG LABEL	12
® Tablets	Bryant Ranch Prepack	2026-05-14	HUMAN PRESCRIPTION DRUG LABEL	106
Hydrochlorothiazide - Preferred Pharmaceuticals, Inc.	Preferred Pharmaceuticals, Inc.	2026-05-11	HUMAN PRESCRIPTION DRUG LABEL	7
® Tablets	Bryant Ranch Prepack	2026-04-14	HUMAN PRESCRIPTION DRUG LABEL	103
® Tablets	Bryant Ranch Prepack	2026-03-31	HUMAN PRESCRIPTION DRUG LABEL	101
Hydrochlorothiazide - ScieGen Pharmaceuticals Inc	ScieGen Pharmaceuticals Inc	2026-02-10	HUMAN PRESCRIPTION DRUG LABEL	6
Hydrochlorothiazide - Northwind Health Company, LLC	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Hydrochlorothiazide - A-S Medication Solutions	A-S Medication Solutions	2025-05-15	HUMAN PRESCRIPTION DRUG LABEL	6
Hydrochlorothiazide - A-S Medication Solutions	A-S Medication Solutions	2023-12-28	HUMAN PRESCRIPTION DRUG LABEL	1
Hydrochlorothiazide Caps 12 5mg - 8344	NCS HealthCare of KY, LLC dba Vangard Labs	2023-10-19	HUMAN PRESCRIPTION DRUG LABEL	6
Hydrochlorothiazide - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2023-04-04	HUMAN PRESCRIPTION DRUG LABEL	1
Hydrochlorothiazide - Denton Pharma, Inc. DBA Northwind Pharmaceuticals	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-06	HUMAN PRESCRIPTION DRUG LABEL	2
Hydrochlorothiazide - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2022-03-10	HUMAN PRESCRIPTION DRUG LABEL	1