Hydrochlorothiazide

Product NDC: 68645-510
11-digit product format: 686450510
Labeler code: 68645
Product ID: 68645-510_4c4a2035-8173-6708-e063-6294a90ad6f2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Legacy Pharmaceutical Packaging, LLC
Application: ANDA083177
Marketing category: ANDA
Marketing start: 1973-01-12
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68645-510	68645-510-01	D	Discontinued by firm		2026-08-17
excluded package	package	68645-510	68645-510-70	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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	68645-510-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	68645-510-70	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	68645-510-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	68645-510-70	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	68645-510-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	68645-510-70	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	68645-510-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	68645-510-70	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	68645-510-70	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	68645-510-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	68645-510-70	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	68645-510-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	68645-510-70	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	68645-510-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	68645-510-70	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	68645-510-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	68645-510-70	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	68645-510-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	68645-510-70	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	68645-510-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	68645-510-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	68645-510-70	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	68645-510-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	68645-510-70	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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	RLD / RS	Approval date
A083177-001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982
A083177-002	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
A083177-003	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	RLD	2024-09-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A083177-001	AB
A083177-002	AB
A083177-003	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 · 95 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
2026-08-18 06:07:40	2026-07	A083177-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083177-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083177-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	RLD	2024-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083177-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083177-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083177-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	RLD	2024-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083177-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083177-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083177-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	RLD	2024-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083177-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083177-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083177-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	RLD	2024-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083177-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083177-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083177-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	RLD	2024-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083177-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083177-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083177-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	RLD	2024-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083177-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083177-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083177-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	RLD	2024-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083177-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083177-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083177-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB	RLD	2024-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083177-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083177-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083177-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083177-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083177-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2024-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083177-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A083177-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A083177-003	HYDROCHLOROTHIAZIDE	12.5MG	TABLET / ORAL	AB		2024-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083177-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083177-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083177-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083177-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083177-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083177-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083177-001	HYDROCHLOROTHIAZIDE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A083177-002	HYDROCHLOROTHIAZIDE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 95 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	A083177-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083177-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083177-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083177-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083177-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083177-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083177-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083177-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083177-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083177-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083177-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083177-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083177-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083177-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083177-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083177-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083177-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083177-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083177-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083177-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083177-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083177-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083177-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083177-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083177-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083177-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083177-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083177-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083177-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083177-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A083177-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A083177-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083177-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083177-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083177-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083177-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083177-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083177-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083177-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A083177-002	AB	1	`8072bd15b7f6…`

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
1d6ea4b4-1e3c-4f3f-989c-1a3a3c0da6bd	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	SPL version
68645-510-01	Hydrochlorothiazide	100 in 1 BOTTLE	TABLET	100	16
68645-510-54	Hydrochlorothiazide	30 in 1 BOTTLE	TABLET	30	16
68645-510-70	Hydrochlorothiazide	30 in 1 BLISTER PACK	TABLET	30	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68645-510-01	EA - Each	68645-510	012e973c-e110-4558-848a-45b834b383ca	1	2016-01-13
68645-510-54	EA - Each	68645-510	edc7004f-7c84-431d-b98d-d81885154abe	1	2017-03-06
68645-510-70	EA - Each	68645-510	960d116c-d4df-4cb4-8754-666639258079	1	2016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68645-510	HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC]	15	Current NDC, Legacy NDC, 3 package rows	20250322_1d6ea4b4-1e3c-4f3f-989c-1a3a3c0da6bd.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Redpharm Drug	57436cfa-9b94-89bf-e063-6394a90aa264	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083177 application number: ANDA083177
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Legacy Pharmaceutical Packaging, LLC	1d6ea4b4-1e3c-4f3f-989c-1a3a3c0da6bd	2026-03-05	Warnings	Exact identifier application applno (ANDA): 083177 application number: ANDA083177 ndc (product): 68645-510
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f7091c54-0984-7f6e-e053-6394a90afb4d	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083177 application number: ANDA083177
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	QPharma, Inc.	c9c44c37-bb49-4364-9293-3c8fd51b759e	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083177 application number: ANDA083177
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	0937d511-4d5e-4aba-bfae-92094c67bcf4	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083177 application number: ANDA083177
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	c182b6a9-1a31-45ee-9cea-a557c99f5db7	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083177 application number: ANDA083177
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	ef8a7dee-3704-4c62-8981-f8adfb47f5d0	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083177 application number: ANDA083177
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	8d5a9196-5f1d-2d83-e053-2a95a90a6036	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083177 application number: ANDA083177
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	852c6f3f-d3f5-0d99-e053-2991aa0aa9c3	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083177 application number: ANDA083177
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Teva Pharmaceuticals USA, Inc.	e2270db4-2930-4ec5-ac96-2b4542aed367	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083177 application number: ANDA083177
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	b9e1bed7-fef9-434a-92f9-b70941176e3e	2023-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083177 application number: ANDA083177
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	b56a3559-6eb2-4a8d-a9a4-232d2ff0febe	2023-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083177 application number: ANDA083177
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	c4fe84e3-c291-4220-95c1-a2bd02b1e134	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083177 application number: ANDA083177
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Aphena Pharma Solutions - Tennessee, LLC	61487122-8a94-4ad5-a307-7893e0b7510c	2017-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083177 application number: ANDA083177

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	1d6ea4b4-1e3c-4f3f-989c-1a3a3c0da6bd	16
310798	hydrochlorothiazide 25 MG Oral Tablet	SCD	1d6ea4b4-1e3c-4f3f-989c-1a3a3c0da6bd	16
310798	HCTZ 25 MG Oral Tablet	SY	1d6ea4b4-1e3c-4f3f-989c-1a3a3c0da6bd	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68645-510-01	68645051001	100 in 1 BOTTLE						Historical
68645-510-54	68645051054	30 TABLET in 1 BOTTLE (68645-510-54)	30 tablet	1973-01-12	0000-00-00	No	No	Current
68645-510-70	68645051070	30 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYDROCHLOROTHIAZIDE TABLETS USP	Legacy Pharmaceutical Packaging, LLC	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL	16