Hydrochlorothiazide

Product NDC: 63629-8498
11-digit product format: 636298498
Labeler code: 63629
Product ID: 63629-8498_8a0cfa86-bdd8-4331-8e83-cc9c06be5cb6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrochlorothiazide
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA203561
Marketing category: ANDA
Marketing start: 2019-01-14
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: 2027-12-31
Current FDA listing: Yes

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

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
A203561-001	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB		2019-01-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203561-001	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.

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
2026-08-01 22:54:32	2026-06	A203561-001	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB		2019-01-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A203561-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	0789baef-3424-43ab-a3fb-4908172da565	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	cb7b7315-0170-492c-803f-60a6e75e55da	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	2b21f3fc-4164-401a-803e-b982dea97e19	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals, Inc.	918391e3-e8b3-4ceb-b4e7-c7c9617ea882	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	ff557069-f177-4e2e-91f4-675a033e2739	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561 ndc (product): 63629-8498
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	45316037-52ec-438f-8780-b2e983fef3f5	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Westminster Pharmaceuticals, LLC	0fc94bc2-fa38-439a-a609-1b4130cdacb1	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	ScieGen Pharmaceuticals Inc	911a18c1-120a-46b3-b7a8-25eb37843473	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	AvPAK	ef56450d-86d3-2654-e053-2995a90a142c	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	f32ce8fe-6cbc-8a15-e053-2995a90a8eec	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	02a481cb-ad80-41bb-82d3-c237b00ed8d7	2025-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	A-S Medication Solutions	bd5728a2-6322-42e3-bd1e-e4915750e398	2023-12-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	NCS HealthCare of KY, LLC dba Vangard Labs	d6b933c6-f5f8-406a-84d6-b22c6040482a	2023-10-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	460f922c-1fda-44a5-889e-d7009883176b	2023-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Aphena Pharma Solutions - Tennessee, LLC	69c41abb-75f4-429b-905a-1ce967924aee	2023-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	b54ec2b1-3325-46a1-b654-8a75dc41ab0a	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Aphena Pharma Solutions - Tennessee, LLC	f0b993f2-9771-42e3-b10e-09719189e2bd	2021-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203561 application number: ANDA203561

Additional Listing Data#

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

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
ff557069-f177-4e2e-91f4-675a033e2739	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
63629-8498-1	Hydrochlorothiazide	500 in 1 BOTTLE	CAPSULE	500		103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8498-1	EA - Each	63629-8498	8d26304a-20e6-4bf4-9fc1-e0b80ba86288	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8498	HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]	102	Current NDC, Legacy NDC, 1 package rows	20240112_ff557069-f177-4e2e-91f4-675a033e2739.zip

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	ff557069-f177-4e2e-91f4-675a033e2739	103
199903	hydrochlorothiazide 12.5 MG Oral Capsule	SCD	ff557069-f177-4e2e-91f4-675a033e2739	103
199903	HCTZ 12.5 MG Oral Capsule	SY	ff557069-f177-4e2e-91f4-675a033e2739	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8498-1	63629849801	500 CAPSULE in 1 BOTTLE (63629-8498-1)	500 capsule	2021-05-18	0000-00-00	No	No	Current