Hydrochlorothiazide

Product NDC: 70518-3749
11-digit product format: 705183749
Labeler code: 70518
Product ID: 70518-3749_4f82e7f9-59bf-6bc2-e063-6294a90a9910
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA040907
Marketing category: ANDA
Marketing start: 2023-06-07
Substance: HYDROCHLOROTHIAZIDE
Active strength: 25 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

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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-3749-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-3749-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-3749-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-3749-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-3749-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-3749-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-3749-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-3749-0	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A040907-001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15
A040907-002	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15
A040907-003	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2025-04-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A040907-001	AB
A040907-002	AB
A040907-003	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 · 92 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
2026-09-14 22:38:34	2026-08	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040907-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2025-04-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040907-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2025-04-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040907-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2025-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040907-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2025-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040907-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2025-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040907-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2008-08-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040907-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2008-08-15	`5d02ea3f76ae…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040907-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040907-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040907-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040907-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040907-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040907-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040907-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040907-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040907-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040907-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040907-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040907-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040907-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040907-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040907-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040907-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040907-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040907-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040907-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040907-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040907-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040907-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040907-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040907-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040907-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040907-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040907-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040907-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040907-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040907-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040907-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040907-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040907-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040907-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040907-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040907-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040907-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040907-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040907-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040907-001	AB	1	`5d02ea3f76ae…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCHLOROTHIAZIDE	25 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
310798	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
2fd8f595-7aec-4308-bb17-a6f2e7190044	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
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
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	Strength	SPL version
70518-3749-0	Hydrochlorothiazide	30 in 1 BLISTER PACK	TABLET	30		6

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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Exelan Pharmaceuticals Inc.	b5a1b38c-0433-4649-a8b0-f72db0a96c45	2018-12-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040907 application number: ANDA040907

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
310798	hydroCHLOROthiazide 25 MG Oral Tablet	PSN	2fd8f595-7aec-4308-bb17-a6f2e7190044	6
310798	hydrochlorothiazide 25 MG Oral Tablet	SCD	2fd8f595-7aec-4308-bb17-a6f2e7190044	6
310798	HCTZ 25 MG Oral Tablet	SY	2fd8f595-7aec-4308-bb17-a6f2e7190044	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-3749-0	70518374900	30 TABLET in 1 BLISTER PACK (70518-3749-0)	30 tablet	2023-06-07	No	No	Current