hydrochlorothiazide

Product NDC: 46708-438
11-digit product format: 467080438
Labeler code: 46708
Product ID: 46708-438_8ed60738-80b1-4c2d-a0f1-cf5fa17f8308
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrochlorothiazide
Dosage form: CAPSULE
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA200645
Marketing category: ANDA
Marketing start: 2017-03-02
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: 2026-12-31
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
A200645-001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL			2010-11-30

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	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	2010-11-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200645-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL		2010-11-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A200645-001	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A200645-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200645-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200645-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200645-001	AB	1	`ea99ee380514…`

Additional Listing Data#

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

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
34703033-14c4-459c-8b8f-2f2e1145aff7	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
46708-438-10	2023-02-01	Hydrochlorothiazide Capsules USP, 12.5 mg Rx only
46708-438-30	2023-02-01	Hydrochlorothiazide Capsules USP, 12.5 mg Rx only
46708-438-31	2023-02-01	Hydrochlorothiazide Capsules USP, 12.5 mg Rx only
46708-438-71	2023-02-01	Hydrochlorothiazide Capsules USP, 12.5 mg Rx only
46708-438-91	2023-02-01	Hydrochlorothiazide Capsules USP, 12.5 mg Rx only
46708-438-10	2023-01-30	Hydrochlorothiazide Capsules USP, 12.5 mg Rx only
46708-438-30	2023-01-30	Hydrochlorothiazide Capsules USP, 12.5 mg Rx only
46708-438-31	2023-01-30	Hydrochlorothiazide Capsules USP, 12.5 mg Rx only
46708-438-71	2023-01-30	Hydrochlorothiazide Capsules USP, 12.5 mg Rx only
46708-438-91	2023-01-30	Hydrochlorothiazide Capsules USP, 12.5 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
46708-438-10	hydrochlorothiazide	10 in 1 BLISTER PACK	CAPSULE	10	3
46708-438-10	hydrochlorothiazide	10 in 1 CARTON	CAPSULE	10	3
46708-438-30	hydrochlorothiazide	30 in 1 BOTTLE	CAPSULE	30	3
46708-438-31	hydrochlorothiazide	100 in 1 BOTTLE	CAPSULE	100	3
46708-438-71	hydrochlorothiazide	500 in 1 BOTTLE	CAPSULE	500	3
46708-438-91	hydrochlorothiazide	1000 in 1 BOTTLE	CAPSULE	1000	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-438	HYDROCHLOROTHIAZIDE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED]	3	Current NDC, Legacy NDC, 6 package rows	20230202_34703033-14c4-459c-8b8f-2f2e1145aff7.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Alembic Pharmaceuticals Limited	34703033-14c4-459c-8b8f-2f2e1145aff7	2023-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200645 application number: ANDA200645 ndc (product): 46708-438
hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Alembic Pharmaceuticals Inc.	841b7962-bf5d-4c45-b594-80b17ba5187d	2020-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200645 application number: ANDA200645

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	34703033-14c4-459c-8b8f-2f2e1145aff7	3
199903	hydrochlorothiazide 12.5 MG Oral Capsule	SCD	34703033-14c4-459c-8b8f-2f2e1145aff7	3
199903	HCTZ 12.5 MG Oral Capsule	SY	34703033-14c4-459c-8b8f-2f2e1145aff7	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-438-10	46708043810	10 BLISTER PACK in 1 CARTON (46708-438-10) / 10 CAPSULE in 1 BLISTER PACK	10 blister pack	2017-03-02	0000-00-00	No	No	Current
46708-438-30	46708043830	30 CAPSULE in 1 BOTTLE (46708-438-30)	30 capsule	2017-03-02	0000-00-00	No	No	Current
46708-438-31	46708043831	100 CAPSULE in 1 BOTTLE (46708-438-31)	100 capsule	2017-03-02	0000-00-00	No	No	Current
46708-438-71	46708043871	500 CAPSULE in 1 BOTTLE (46708-438-71)	500 capsule	2017-03-02	0000-00-00	No	No	Current
46708-438-91	46708043891	1000 CAPSULE in 1 BOTTLE (46708-438-91)	1000 capsule	2017-03-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrochlorothiazide Capsules USP, 12.5 mg Rx only	Alembic Pharmaceuticals Limited	2023-01-30	Human Prescription Drug Label	3