Hydrochlorothiazide

Product NDC: 55289-565
Requested package NDC: 55289-565-30
11-digit product format: 552890565
Labeler code: 55289
Product ID: 55289-565_da303b38-c917-b559-e053-2995a90ad08b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydrochlorothiazide
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: NDA020504
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 1996-12-27
Marketing end: 0000-00-00
Substance: HYDROCHLOROTHIAZIDE
Active strength: 13 mg/1
Pharmacologic classes: Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55289-565	55289-565-30	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 · 12 matching rows.

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

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

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
N020504-001	MICROZIDE	HYDROCHLOROTHIAZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020504-001	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.

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020504-001	MICROZIDE	12.5MG	CAPSULE / ORAL	AB	RLD, RS	1996-12-27	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	N020504-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020504-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020504-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020504-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020504-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020504-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020504-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020504-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020504-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020504-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020504-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020504-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020504-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020504-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020504-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020504-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020504-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020504-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020504-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020504-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020504-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020504-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020504-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020504-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020504-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020504-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020504-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020504-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020504-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020504-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020504-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020504-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020504-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020504-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020504-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020504-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020504-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020504-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020504-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020504-001	AB	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55289-565-07	EA - Each	55289-565	780b10ec-0968-49c9-914d-bf8252fec903	1	2018-04-19
55289-565-14	EA - Each	55289-565	c3ea5dfd-23a0-40e4-bf54-69af52fd2343	1	2017-06-15
55289-565-30	EA - Each	55289-565	a095beaf-54b4-436c-9599-86cac4fb9661	1	2012-07-24
55289-565-60	EA - Each	55289-565	a1399da7-febd-4e86-94f6-5bf09d27db7d	1	2015-08-04
55289-565-90	EA - Each	55289-565	22d0101f-7427-4e8d-af2d-b3fc4fb68395	1	2015-05-05
55289-565-98	EA - Each	55289-565	95d1c7be-e2cc-4a37-8d44-315d2b0e92ae	1	2015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	10
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	10
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	10
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	10
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	10
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	10
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	10
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	10
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	10
GELATIN	INACTIVE INGREDIENT	2G86QN327L	HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	10
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	10
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.]	10

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	QPharma, Inc.	5bacc909-6b02-4815-85ef-55fd25b1b1f7	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020504 application number: NDA020504
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Actavis Pharma, Inc.	a3eb7294-f913-434b-896c-da028bfebc73	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020504 application number: NDA020504
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Proficient Rx LP	c1052d38-fd75-40c2-a685-0e889009be0b	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020504 application number: NDA020504
Hydrochlorothiazide	HYDROCHLOROTHIAZIDE	Aphena Pharma Solutions - Tennessee, LLC	0f7a608d-748b-49a9-a4b3-b3fdcab53ce0	2017-12-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020504 application number: NDA020504

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55289-565-30	55289056530	30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (55289-565-30)	2015-12-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrochlorothiazide Capsule	PD-Rx Pharmaceuticals, Inc.	2022-03-14	HUMAN PRESCRIPTION DRUG LABEL	22