Hydrochlorothiazide

Product NDC: 68071-3323
11-digit product format: 680713323
Labeler code: 68071
Product ID: 68071-3323_1cd709d4-ae48-e5f8-e063-6294a90a07ee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA202556
Marketing category: ANDA
Marketing start: 2013-04-10
Substance: HYDROCHLOROTHIAZIDE
Active strength: 50 mg/1
Pharmacologic classes: Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 20 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
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-3323-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-3323-9	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-3323-6	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-3323-5	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-3323-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-3323-9	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-3323-6	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-3323-5	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-3323-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-3323-9	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-3323-6	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-3323-5	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-3323-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-3323-9	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-3323-6	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-3323-5	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A202556-001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	2012-09-24
A202556-002	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	2012-09-24
A202556-003	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	2012-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202556-001	AB
A202556-002	AB
A202556-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202556-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2012-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202556-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB		2012-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202556-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB		2012-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202556-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2012-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202556-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB		2012-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202556-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB		2012-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202556-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2012-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202556-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB		2012-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202556-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB		2012-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202556-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2012-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202556-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB		2012-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202556-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB		2012-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202556-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2012-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202556-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB		2012-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202556-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB		2012-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202556-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2012-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202556-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB		2012-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202556-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB		2012-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202556-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2012-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202556-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB		2012-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202556-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB		2012-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202556-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	RS	2012-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202556-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB		2012-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202556-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB		2012-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202556-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	RS	2012-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202556-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB		2012-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202556-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB		2012-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202556-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	RS	2012-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202556-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB		2012-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202556-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB		2012-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202556-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	RS	2012-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202556-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB		2012-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202556-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB		2012-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202556-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	RS	2012-09-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202556-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB		2012-09-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202556-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB		2012-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202556-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	RS	2012-09-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202556-002	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB		2012-09-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202556-003	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB		2012-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202556-001	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	RS	2012-09-24	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A202556-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202556-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202556-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202556-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202556-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202556-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202556-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202556-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202556-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202556-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202556-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202556-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202556-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202556-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202556-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202556-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202556-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202556-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202556-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202556-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202556-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202556-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202556-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202556-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202556-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202556-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202556-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202556-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202556-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202556-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202556-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202556-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202556-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202556-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202556-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202556-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202556-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202556-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202556-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202556-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Hydrochlorothiazide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCHLOROTHIAZIDE	50 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
197770	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
53fe1730-a803-26b2-e054-00144ff88e88	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68071-3323-3	2024-07-09	HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only
68071-3323-5	2024-07-09	HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only
68071-3323-6	2024-07-09	HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only
68071-3323-9	2024-07-09	HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only
68071-3323-3	2023-01-30	HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only
68071-3323-5	2023-01-30	HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only
68071-3323-6	2023-01-30	HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only
68071-3323-9	2023-01-30	HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only
68071-3323-3	2021-02-12	HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only
68071-3323-5	2021-02-12	HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only
68071-3323-6	2021-02-12	HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only
68071-3323-9	2021-02-12	HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only
68071-3323-3	2021-01-29	HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only
68071-3323-5	2021-01-29	HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only
68071-3323-6	2021-01-29	HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only
68071-3323-9	2021-01-29	HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-3323-3	Hydrochlorothiazide	30 in 1 BOTTLE	TABLET	30	5
68071-3323-5	Hydrochlorothiazide	15 in 1 BOTTLE	TABLET	15	5
68071-3323-6	Hydrochlorothiazide	60 in 1 BOTTLE	TABLET	60	5
68071-3323-9	Hydrochlorothiazide	90 in 1 BOTTLE	TABLET	90	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3323	HYDROCHLOROTHIAZIDE TABLET [NUCARE PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 4 package rows	20240711_53fe1730-a803-26b2-e054-00144ff88e88.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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	a013211e-b8f8-426d-8e55-e86193f0634e	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202556 application number: ANDA202556
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	f22a10a2-8f84-4060-9143-427237c51280	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202556 application number: ANDA202556
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	27a7e751-8aca-440e-95e4-cfecae1a2465	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202556 application number: ANDA202556
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Accord Healthcare Inc.	babb1b20-fe82-40ba-8e7a-0c56fe433b4a	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202556 application number: ANDA202556
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	c2db7e27-952f-c3f6-e053-2995a90af7c1	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202556 application number: ANDA202556
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	c2d993ff-b11b-7a62-e053-2995a90a0b00	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202556 application number: ANDA202556
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	57a2f9bd-8ca5-437e-b911-5207f94cc6ba	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202556 application number: ANDA202556
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	ab8115a0-e96f-7aee-e053-2995a90a6ec0	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202556 application number: ANDA202556
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f3191ca2-4dbc-01f5-e053-2a95a90a572c	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202556 application number: ANDA202556
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	DIRECT RX	cbe5e01e-67ca-f8a2-e053-2995a90a0d15	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202556 application number: ANDA202556
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals, Inc.	3e35fb03-9173-6731-e054-00144ff8d46c	2024-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202556 application number: ANDA202556
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals, Inc.	53fe1730-a803-26b2-e054-00144ff88e88	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202556 application number: ANDA202556 ndc (product): 68071-3323
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	98a58b54-bcf2-4726-800a-facf48d9155f	2024-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202556 application number: ANDA202556
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	5de62aee-f3cc-4aaa-8588-2aed2bdeced9	2023-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202556 application number: ANDA202556
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	54224596-325d-473e-adb5-1c86857aba34	2023-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202556 application number: ANDA202556
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	48b4d633-ecfa-4748-80e8-6c0e3d8b067e	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202556 application number: ANDA202556
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	fd9b3e5a-f564-4730-8b9f-2cdc2953cbc9	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202556 application number: ANDA202556
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	78c04f59-65c3-4a16-83a6-ed4a409afce5	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202556 application number: ANDA202556

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
197770	hydroCHLOROthiazide 50 MG Oral Tablet	PSN	53fe1730-a803-26b2-e054-00144ff88e88	5
197770	hydrochlorothiazide 50 MG Oral Tablet	SCD	53fe1730-a803-26b2-e054-00144ff88e88	5
197770	HCTZ 50 MG Oral Tablet	SY	53fe1730-a803-26b2-e054-00144ff88e88	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-3323-3	68071332303	30 TABLET in 1 BOTTLE (68071-3323-3)	30 tablet	2017-07-10	0000-00-00	No	No	Current
68071-3323-5	68071332305	15 TABLET in 1 BOTTLE (68071-3323-5)	15 tablet	2017-07-10	0000-00-00	No	No	Current
68071-3323-6	68071332306	60 TABLET in 1 BOTTLE (68071-3323-6)	60 tablet	2017-07-10	0000-00-00	No	No	Current
68071-3323-9	68071332309	90 TABLET in 1 BOTTLE (68071-3323-9)	90 tablet	2017-07-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only	NuCare Pharmaceuticals, Inc.	2024-07-09	HUMAN PRESCRIPTION DRUG LABEL	5