Hydrochlorothiazide

Product NDC: 43063-933
Requested package NDC: 43063-933-01
11-digit product format: 430630933
Labeler code: 43063
Product ID: 43063-933_dafcb77d-8850-615d-e053-2a95a90a4c5a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA040412
Marketing category: ANDA
Marketing start: 2002-03-29
Marketing end: 0000-00-00
Substance: HYDROCHLOROTHIAZIDE
Active strength: 25 mg/1
Pharmacologic classes: Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	43063-933	43063-933-01	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-933	43063-933-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-933	43063-933-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

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
A040412-001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL			2002-03-29
A040412-002	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL			2002-03-29

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 · 84 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	A040412-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2002-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040412-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2002-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040412-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2002-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040412-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2002-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040412-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2002-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040412-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2002-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040412-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2002-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040412-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2002-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040412-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2002-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040412-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2002-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040412-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2002-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040412-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2002-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040412-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2002-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040412-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2002-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040412-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2002-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040412-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2002-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040412-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2002-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040412-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2002-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040412-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2002-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040412-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2002-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040412-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL		2002-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040412-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL		2002-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040412-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2002-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040412-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2002-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040412-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2002-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040412-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2002-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040412-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2002-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040412-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2002-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040412-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2002-03-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040412-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2002-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040412-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2002-03-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040412-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2002-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040412-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2002-03-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040412-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2002-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040412-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2002-03-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040412-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2002-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040412-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2002-03-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040412-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2002-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040412-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2002-03-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040412-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2002-03-29	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040412-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040412-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040412-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040412-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040412-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040412-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040412-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040412-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040412-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040412-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040412-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040412-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040412-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040412-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040412-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040412-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040412-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040412-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040412-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040412-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040412-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040412-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040412-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040412-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040412-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040412-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040412-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040412-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040412-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040412-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040412-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040412-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040412-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040412-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040412-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040412-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040412-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A040412-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040412-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A040412-002	AB	1	`ea1830bbd6c7…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-933-01	EA - Each	43063-933	9afcd2e8-ad77-4805-b2eb-3e5c0db10382	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-933	HYDROCHLOROTHIAZIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	9	Legacy NDC	20241018_b0356653-8467-439a-8fa2-c5aa3d81d475.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	American Health Packaging	c8de63da-b6c0-42f0-9d47-e273fe93adb3	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040412 application number: ANDA040412
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	5f2e72cc-073d-4bb5-95fe-53d4060127ec	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040412 application number: ANDA040412
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	78d65a02-c78e-4f98-b756-3cb5ee78f252	2024-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040412 application number: ANDA040412
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	24cba606-263f-46dc-a4dc-fddc729c0f4b	2023-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040412 application number: ANDA040412
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	4c3403a6-da6a-4f37-bc7e-9fe0aa284305	2021-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040412 application number: ANDA040412
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	0fdb6713-8013-4cfe-a776-0c1e9414a91c	2020-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040412 application number: ANDA040412
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Solco Healthcare U.S., LLC	60c97ab9-b25e-4ea5-a159-792292178c65	2020-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040412 application number: ANDA040412

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-933-01	43063093301	100 TABLET in 1 BOTTLE, PLASTIC (43063-933-01)	100 tablet	2019-01-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROCHLOROTHIAZIDE TABLETS, USP 25 mg	PD-Rx Pharmaceuticals, Inc.	2024-10-16	HUMAN PRESCRIPTION DRUG LABEL	9