Fosinopril Sodium and Hydrochlorothiazide

Product NDC: 69097-973
11-digit product format: 690970973
Labeler code: 69097
Product ID: 69097-973_25e66ad5-947a-4262-a996-a9695601d301
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fosinopril Sodium and Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: CIPLA USA INC.
Application: ANDA090228
Marketing category: ANDA
Marketing start: 2020-07-24
Substance: FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
Active strength: 20; 12.5 mg/1; mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], 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 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB		2009-07-09
A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB		2009-07-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090228-001	AB
A090228-002	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 · 88 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
2026-10-15 13:18:30	2026-09	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090228-001	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	10MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090228-002	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	20MG;12.5MG	TABLET / ORAL	AB	2009-07-09	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A090228-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090228-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090228-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090228-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090228-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090228-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090228-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090228-002	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FOSINOPRIL SODIUM	20 mg/1
HYDROCHLOROTHIAZIDE	12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0J48LPH2TH	Internal UNII lookup
NW2RTH6T2N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
857166	Internal RxNorm lookup
857174	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
4e1ed7da-029e-48d6-a5e4-fc7ac11192fb	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
90aa3f6a-97f0-be7e-d25b-b26d56ae287e	Product name	3	20201015
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
69097-973-07	Fosinopril Sodium and Hydrochlorothiazide	100 in 1 BOTTLE	TABLET	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69097-973-07	EA - Each	69097-973	a94f0546-71cd-469d-abc5-2a529137be41	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-973	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLET [CIPLA USA INC.]	2	Current NDC, Legacy NDC, 1 package rows	20201106_4e1ed7da-029e-48d6-a5e4-fc7ac11192fb.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fosinopril Sodium and Hydrochlorothiazide	FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	CIPLA USA INC.	4e1ed7da-029e-48d6-a5e4-fc7ac11192fb	2020-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090228 application number: ANDA090228 ndc (product): 69097-973

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NW2RTH6T2N	FOSINOPRIL SODIUM	88889-14-9	FOSINOPRIL SODIUM
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857166	fosinopril sodium 10 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	4e1ed7da-029e-48d6-a5e4-fc7ac11192fb	2
857174	fosinopril sodium 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	4e1ed7da-029e-48d6-a5e4-fc7ac11192fb	2
857166	fosinopril sodium 10 MG / hydrochlorothiazide 12.5 MG Oral Tablet	SCD	4e1ed7da-029e-48d6-a5e4-fc7ac11192fb	2
857174	fosinopril sodium 20 MG / hydrochlorothiazide 12.5 MG Oral Tablet	SCD	4e1ed7da-029e-48d6-a5e4-fc7ac11192fb	2
857166	FNP Sodium 10 MG / HCTZ 12.5 MG Oral Tablet	SY	4e1ed7da-029e-48d6-a5e4-fc7ac11192fb	2
857174	FNP Sodium 20 MG / HCTZ 12.5 MG Oral Tablet	SY	4e1ed7da-029e-48d6-a5e4-fc7ac11192fb	2
857166	fosinopril sodium 10 MG / HCTZ 12.5 MG Oral Tablet	SY	4e1ed7da-029e-48d6-a5e4-fc7ac11192fb	2
857174	fosinopril sodium 20 MG / HCTZ 12.5 MG Oral Tablet	SY	4e1ed7da-029e-48d6-a5e4-fc7ac11192fb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69097-973-07	69097097307	100 TABLET in 1 BOTTLE (69097-973-07)	100 tablet	2020-07-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fosinopril Sodium and Hydrochlorothiazide Tablets, USP	CIPLA USA INC. \| InvaGen Pharmaceuticals, Inc	2020-11-03	HUMAN PRESCRIPTION DRUG LABEL	2