Fosinopril sodium

Product NDC: 67544-431
11-digit product format: 675440431
Labeler code: 67544
Product ID: 67544-431_da02b76d-00ea-4733-aef8-7808b0b45d47
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fosinopril sodium
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA077222
Marketing category: ANDA
Marketing start: 2005-06-21
Marketing end: 0000-00-00
Substance: FOSINOPRIL SODIUM
Active strength: 20 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67544-431		I	Inactivated by FDA	2026-08-17
excluded package	package	67544-431	67544-431-15	I	Inactivated by FDA	2026-08-17
excluded package	package	67544-431	67544-431-30	I	Inactivated by FDA	2026-08-17
excluded package	package	67544-431	67544-431-45	I	Inactivated by FDA	2026-08-17
excluded package	package	67544-431	67544-431-53	I	Inactivated by FDA	2026-08-17
excluded package	package	67544-431	67544-431-60	I	Inactivated by FDA	2026-08-17
excluded package	package	67544-431	67544-431-70	I	Inactivated by FDA	2026-08-17
excluded package	package	67544-431	67544-431-73	I	Inactivated by FDA	2026-08-17
excluded package	package	67544-431	67544-431-80	I	Inactivated by FDA	2026-08-17
excluded package	package	67544-431	67544-431-92	I	Inactivated by FDA	2026-08-17
excluded package	package	67544-431	67544-431-94	I	Inactivated by FDA	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 4 · 231 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-431-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-431-73	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-431-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-431-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-431-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-431-70	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-431-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-431-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-431-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-431-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-431-94	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-431-73	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-431-92	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-431-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-431-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-431-70	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-431-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-431-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-431-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-431-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-431-94	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-431-73	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-431-92	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-431-53	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-431-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-431-70	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-431-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-431-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-431-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-431-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-431-94	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-431-73	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-431-92	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-431-53	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-431-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-431-70	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-431-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-431-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-431-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-431-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-431-94	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-431-73	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-431-92	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-431-53	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-431-80	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-431-70	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-431-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-431-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-431-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-431-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-431-94	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-431-73	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-431-92	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-431-53	`cdf11ea48f46…`	`ba0047e9e063…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077222-001	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20
A077222-002	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20
A077222-003	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077222-001	AB
A077222-002	AB
A077222-003	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 4 · 126 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	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077222-002	FOSINOPRIL SODIUM	20MG	TABLET / ORAL	AB	2005-04-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077222-003	FOSINOPRIL SODIUM	40MG	TABLET / ORAL	AB	2005-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077222-001	FOSINOPRIL SODIUM	10MG	TABLET / ORAL	AB	2005-04-20	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A077222-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077222-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077222-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077222-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077222-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077222-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077222-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077222-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077222-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077222-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077222-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077222-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077222-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077222-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077222-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077222-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077222-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077222-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077222-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077222-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077222-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077222-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077222-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077222-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077222-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077222-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077222-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077222-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077222-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077222-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077222-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077222-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077222-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077222-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077222-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077222-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077222-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077222-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077222-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077222-001	AB	1	`1e350fbaab3a…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
90aa3f6a-97f0-be7e-d25b-b26d56ae287e	Product name	3	20201015

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
67544-431-15	Rx only
67544-431-30	Rx only
67544-431-45	Rx only
67544-431-53	Rx only
67544-431-60	Rx only
67544-431-70	Rx only
67544-431-73	Rx only
67544-431-80	Rx only
67544-431-92	Rx only
67544-431-94	Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67544-431-15	Fosinopril sodium	15 in 1 BOTTLE, PLASTIC	TABLET	15	2
67544-431-30	Fosinopril sodium	30 in 1 BOTTLE, PLASTIC	TABLET	30	2
67544-431-45	Fosinopril sodium	45 in 1 BOTTLE, PLASTIC	TABLET	45	2
67544-431-53	Fosinopril sodium	60 in 1 BOTTLE, PLASTIC	TABLET	60	2
67544-431-60	Fosinopril sodium	90 in 1 BOTTLE, PLASTIC	TABLET	90	2
67544-431-70	Fosinopril sodium	120 in 1 BOTTLE, PLASTIC	TABLET	120	2
67544-431-73	Fosinopril sodium	135 in 1 BOTTLE, PLASTIC	TABLET	135	2
67544-431-80	Fosinopril sodium	180 in 1 BOTTLE, PLASTIC	TABLET	180	2
67544-431-92	Fosinopril sodium	270 in 1 BOTTLE, PLASTIC	TABLET	270	2
67544-431-94	Fosinopril sodium	360 in 1 BOTTLE, PLASTIC	TABLET	360	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67544-431-15	EA - Each	67544-431	58ac496d-2b88-4807-be23-fd331423574c	1	2014-07-02
67544-431-30	EA - Each	67544-431	f5309689-fafb-4692-ad15-86c73ce00498	1	2014-08-01
67544-431-45	EA - Each	67544-431	163ca1cb-4ef4-41fd-99c0-1a73e0e22a04	1	2014-08-01
67544-431-53	EA - Each	67544-431	b426c7b2-d539-4a21-b170-63824a7df95a	1	2014-08-01
67544-431-60	EA - Each	67544-431	c6c93bd7-e4b3-4d54-89c9-0347c031256f	1	2014-08-01
67544-431-70	EA - Each	67544-431	ec1948a7-bb77-4e28-8d0c-3b99ba0981aa	1	2014-08-01
67544-431-73	EA - Each	67544-431	f35b2a46-434a-40aa-a0d0-75fbb4cfcb1e	1	2014-08-01
67544-431-80	EA - Each	67544-431	2e4f1d72-e40a-4854-aa1e-ead788172a6a	1	2014-08-01
67544-431-92	EA - Each	67544-431	732a2b8e-df9a-4992-956a-0cf10c2364b5	1	2014-08-01
67544-431-94	EA - Each	67544-431	e1d472b8-391b-434a-9442-da1fcefff075	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FOSINOPRIL SODIUM	ACTIVE INGREDIENT	NW2RTH6T2N	FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FOSINOPRILAT	ACTIVE MOIETY	S312EY6ZT8	FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67544-431	FOSINOPRIL SODIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC, 10 package rows	20140717_0524fc86-caae-4d95-8a65-551ce99637e8.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fosinopril Sodium	FOSINOPRIL	Bryant Ranch Prepack	fc38f1bb-f175-4a81-8ed9-c8701efdea35	2023-11-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077222 application number: ANDA077222
Fosinopril Sodium	FOSINOPRIL	Bryant Ranch Prepack	6562a532-b502-4515-88df-591d71293b56	2023-10-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077222 application number: ANDA077222
Fosinopril sodium	FOSINOPRIL SODIUM	Exelan Pharmaceuticals, Inc.	e2ff3171-a17a-456a-9272-ca1682b01d19	2023-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077222 application number: ANDA077222
Fosinopril Sodium	FOSINOPRIL	A-S Medication Solutions	880e5bf4-ced8-4765-a5c2-2361fd06ed9c	2023-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077222 application number: ANDA077222
Fosinopril Sodium	FOSINOPRIL	Cipla USA Inc.	736fe52f-69fb-48b2-b1c5-f06531878538	2023-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077222 application number: ANDA077222

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NW2RTH6T2N	FOSINOPRIL SODIUM	88889-14-9	FOSINOPRIL SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857183	fosinopril sodium 20 MG Oral Tablet	PSN	0524fc86-caae-4d95-8a65-551ce99637e8	2
857183	fosinopril sodium 20 MG Oral Tablet	SCD	0524fc86-caae-4d95-8a65-551ce99637e8	2
857183	FNP Sodium 20 MG Oral Tablet	SY	0524fc86-caae-4d95-8a65-551ce99637e8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
67544-431-15	67544043115	15 in 1 BOTTLE, PLASTIC	Historical
67544-431-30	67544043130	30 in 1 BOTTLE, PLASTIC	Historical
67544-431-45	67544043145	45 in 1 BOTTLE, PLASTIC	Historical
67544-431-53	67544043153	60 in 1 BOTTLE, PLASTIC	Historical
67544-431-60	67544043160	90 in 1 BOTTLE, PLASTIC	Historical
67544-431-70	67544043170	120 in 1 BOTTLE, PLASTIC	Historical
67544-431-73	67544043173	135 in 1 BOTTLE, PLASTIC	Historical
67544-431-80	67544043180	180 in 1 BOTTLE, PLASTIC	Historical
67544-431-92	67544043192	270 in 1 BOTTLE, PLASTIC	Historical
67544-431-94	67544043194	360 in 1 BOTTLE, PLASTIC	Historical