ALTACE

Product NDC: 61570-110
11-digit product format: 615700110
Labeler code: 61570
Product ID: 61570-110_7c58ba31-97ac-4b94-93c7-d6c9868df832
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ramipril
Dosage form: CAPSULE
Route: ORAL
Labeler: Pfizer Laboratories Div Pfizer Inc
Application: NDA019901
Marketing category: NDA
Marketing start: 1991-01-28
Marketing end: 0000-00-00
Substance: RAMIPRIL
Active strength: 1 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61570-110		D	Discontinued by firm		2026-10-16
excluded package	package	61570-110	61570-110-01	D	Discontinued by firm		2026-10-16

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 · 18 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	61570-110-01	`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	61570-110-01	`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	61570-110-01	`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	61570-110-01	`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	61570-110-01	`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	61570-110-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61570-110-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61570-110-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61570-110-01	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N019901-001	ALTACE	RAMIPRIL	1.25MG	CAPSULE / ORAL	RLD	1991-01-28
N019901-002	ALTACE	RAMIPRIL	2.5MG	CAPSULE / ORAL	RLD	1991-01-28
N019901-003	ALTACE	RAMIPRIL	5MG	CAPSULE / ORAL	RLD	1991-01-28
N019901-004	ALTACE	RAMIPRIL	10MG	CAPSULE / ORAL	RLD	1991-01-28

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 5 · 176 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
2026-10-15 13:18:30	2026-09	N019901-001	ALTACE	1.25MG	CAPSULE / ORAL		RLD	1991-01-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019901-002	ALTACE	2.5MG	CAPSULE / ORAL		RLD	1991-01-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019901-003	ALTACE	5MG	CAPSULE / ORAL		RLD	1991-01-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019901-004	ALTACE	10MG	CAPSULE / ORAL		RLD	1991-01-28	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N019901-001	ALTACE	1.25MG	CAPSULE / ORAL		RLD	1991-01-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019901-002	ALTACE	2.5MG	CAPSULE / ORAL		RLD	1991-01-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019901-003	ALTACE	5MG	CAPSULE / ORAL		RLD	1991-01-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019901-004	ALTACE	10MG	CAPSULE / ORAL		RLD	1991-01-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019901-001	ALTACE	1.25MG	CAPSULE / ORAL		RLD	1991-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019901-002	ALTACE	2.5MG	CAPSULE / ORAL		RLD	1991-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019901-003	ALTACE	5MG	CAPSULE / ORAL		RLD	1991-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019901-004	ALTACE	10MG	CAPSULE / ORAL		RLD	1991-01-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019901-001	ALTACE	1.25MG	CAPSULE / ORAL		RLD	1991-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019901-002	ALTACE	2.5MG	CAPSULE / ORAL		RLD	1991-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019901-003	ALTACE	5MG	CAPSULE / ORAL		RLD	1991-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019901-004	ALTACE	10MG	CAPSULE / ORAL		RLD	1991-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019901-001	ALTACE	1.25MG	CAPSULE / ORAL		RLD	1991-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019901-002	ALTACE	2.5MG	CAPSULE / ORAL		RLD	1991-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019901-003	ALTACE	5MG	CAPSULE / ORAL		RLD	1991-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019901-004	ALTACE	10MG	CAPSULE / ORAL		RLD	1991-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019901-001	ALTACE	1.25MG	CAPSULE / ORAL		RLD	1991-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019901-002	ALTACE	2.5MG	CAPSULE / ORAL		RLD	1991-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019901-003	ALTACE	5MG	CAPSULE / ORAL		RLD	1991-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019901-004	ALTACE	10MG	CAPSULE / ORAL		RLD	1991-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019901-001	ALTACE	1.25MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019901-002	ALTACE	2.5MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019901-003	ALTACE	5MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019901-004	ALTACE	10MG	CAPSULE / ORAL	AB	RLD, RS	1991-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019901-001	ALTACE	1.25MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019901-002	ALTACE	2.5MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019901-003	ALTACE	5MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019901-004	ALTACE	10MG	CAPSULE / ORAL	AB	RLD, RS	1991-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019901-001	ALTACE	1.25MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019901-002	ALTACE	2.5MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019901-003	ALTACE	5MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019901-004	ALTACE	10MG	CAPSULE / ORAL	AB	RLD, RS	1991-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019901-001	ALTACE	1.25MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019901-002	ALTACE	2.5MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019901-003	ALTACE	5MG	CAPSULE / ORAL	AB	RLD	1991-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019901-004	ALTACE	10MG	CAPSULE / ORAL	AB	RLD, RS	1991-01-28	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 148 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	N019901-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019901-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019901-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019901-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019901-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019901-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019901-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019901-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019901-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019901-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019901-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019901-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019901-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019901-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019901-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019901-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019901-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019901-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019901-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019901-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019901-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019901-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019901-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019901-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019901-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019901-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019901-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019901-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019901-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019901-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019901-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019901-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019901-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019901-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019901-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019901-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019901-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019901-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019901-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019901-004	AB	1	`8869cabd3fbd…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019901-001	7368469	2020-08-30	U-871	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019901-002	7368469	2020-08-30	U-871	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019901-003	7368469	2020-08-30	U-871	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019901-004	7368469	2020-08-30	U-871	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N019901-001	7368469	2020-08-30	U-871	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019901-002	7368469	2020-08-30	U-871	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019901-003	7368469	2020-08-30	U-871	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019901-004	7368469	2020-08-30	U-871	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019901-001	7368469	2020-08-30	U-871	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019901-002	7368469	2020-08-30	U-871	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019901-003	7368469	2020-08-30	U-871	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019901-004	7368469	2020-08-30	U-871	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019901-001	7368469	2020-08-30	U-871	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019901-002	7368469	2020-08-30	U-871	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019901-003	7368469	2020-08-30	U-871	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019901-004	7368469	2020-08-30	U-871	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019901-001	7368469	2020-08-30	U-871	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019901-002	7368469	2020-08-30	U-871	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019901-003	7368469	2020-08-30	U-871	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019901-004	7368469	2020-08-30	U-871	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019901-001	7368469	2020-08-30	U-871	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019901-002	7368469	2020-08-30	U-871	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019901-003	7368469	2020-08-30	U-871	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019901-004	7368469	2020-08-30	U-871	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9a7d2f1c-330a-4830-b88b-315f5c1bab6b	Product name	1	20151208
c76eceed-99b6-9572-9f36-9ac63b4b3ce4	Product name	2	20141218

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61570-110-01	EA - Each	61570-110	41d6863d-cc10-4ce8-b624-c1e8ca2d0379	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RAMIPRIL	ACTIVE INGREDIENT	L35JN3I7SJ	ALTACE (RAMIPRIL) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]	15
RAMIPRILAT	ACTIVE MOIETY	6N5U4QFC3G	ALTACE (RAMIPRIL) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]	15
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ALTACE (RAMIPRIL) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]	15
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ALTACE (RAMIPRIL) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]	15
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ALTACE (RAMIPRIL) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]	15
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ALTACE (RAMIPRIL) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]	15
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ALTACE (RAMIPRIL) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]	15
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALTACE (RAMIPRIL) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ALTACE (RAMIPRIL) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61570-110	ALTACE (RAMIPRIL) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]	27	Legacy NDC	20250109_0fc34cd8-86e6-4034-73bd-4263a68ba046.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L35JN3I7SJ	RAMIPRIL	87333-19-5	RAMIPRIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61570-110-01	61570011001	100 CAPSULE in 1 BOTTLE (61570-110-01)	100 capsule	1991-01-28	0000-00-00	No	No	Current