Application 020504

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MICROZIDE	HYDROCHLOROTHIAZIDE	CAPSULE;ORAL	12.5MG	Yes	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
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…`

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 ndc (product): 42708-027
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 ndc (product): 0591-0347
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 ndc (product): 63187-548
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 ndc (product): 67544-739

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-6154	Microzide	Hydrochlorothiazide	Allergan, Inc.	NDA	Current
0023-6154	Microzide	Hydrochlorothiazide	Allergan, Inc.	NDA	Current
0591-0347	Hydrochlorothiazide	Hydrochlorothiazide	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-0347	Hydrochlorothiazide	Hydrochlorothiazide	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-0347	Hydrochlorothiazide	Hydrochlorothiazide	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-0347	Hydrochlorothiazide	Hydrochlorothiazide	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-0347	Hydrochlorothiazide	Hydrochlorothiazide	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0615-1358	Hydrochlorothiazide	Hydrochlorothiazide	NCS HealthCare of KY, Inc dba Vangard Labs	NDA AUTHORIZED GENERIC	Current
10544-197	Hydrochlorothiazide	Hydrochlorothiazide	Blenheim Pharmacal, Inc.	NDA AUTHORIZED GENERIC	Current
10544-198	Hydrochlorothiazide	Hydrochlorothiazide	Blenheim Pharmacal, Inc.	NDA AUTHORIZED GENERIC	Current
42708-027	Hydrochlorothiazide	Hydrochlorothiazide	QPharma Inc	NDA AUTHORIZED GENERIC	Current
42708-027	Hydrochlorothiazide	Hydrochlorothiazide	QPharma Inc	NDA AUTHORIZED GENERIC	Current
42708-027	Hydrochlorothiazide	Hydrochlorothiazide	QPharma Inc	NDA AUTHORIZED GENERIC	Current
52544-622	Microzide	Hydrochlorothiazide	Actavis Pharma, Inc.	NDA	Current
55289-565	Hydrochlorothiazide	Hydrochlorothiazide	PD-Rx Pharmaceuticals, In	NDA AUTHORIZED	Current
55289-565	Hydrochlorothiazide	Hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
55289-565	Hydrochlorothiazide	Hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
55289-565	Hydrochlorothiazide	Hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
55289-565	Hydrochlorothiazide	Hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
55289-565	Hydrochlorothiazide	Hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
55289-565	Hydrochlorothiazide	Hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
55289-565	Hydrochlorothiazide	Hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
63187-548	Hydrochlorothiazide	Hydrochlorothiazide	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
63187-548	Hydrochlorothiazide	Hydrochlorothiazide	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
63187-548	Hydrochlorothiazide	Hydrochlorothiazide	Proficient Rx LP	NDA AUTHORIZED GENERIC	Current
63629-6463	Hydrochlorothiazide	Hydrochlorothiazide	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-6463	Hydrochlorothiazide	Hydrochlorothiazide	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
67544-739	Hydrochlorothiazide	Hydrochlorothiazide	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
68071-4176	Hydrochlorothiazide	Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68071-4176	Hydrochlorothiazide	Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68788-9867	Hydrochlorothiazide	Hydrochlorothiazide	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64354	SUPPL	2020-08-21
64332	SUPPL	2020-08-20
34721	SUPPL	2011-03-21
25058	SUPPL	2011-03-21