RAMIPRIL

Product NDC: 61919-179
11-digit product format: 619190179
Labeler code: 61919
Product ID: 61919-179_9cad1861-e8e9-0ee6-e053-2995a90aba73
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: RAMIPRIL
Dosage form: CAPSULE
Route: ORAL
Labeler: DirectRX
Application: ANDA077470
Marketing category: ANDA
Marketing start: 2015-01-01
Marketing end: 0000-00-00
Substance: RAMIPRIL
Active strength: 10 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	61919-179		I	Inactivated by FDA		2026-10-12
excluded package	package	61919-179	61919-179-90	I	Inactivated by FDA		2026-10-12

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 · 32 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-179-90	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-179-90	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-179-90	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-179-90	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-179-90	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-179-90	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-179-90	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-179-90	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-179-90	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-179-90	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-179-90	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-179-90	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-179-90	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-179-90	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-179-90	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61919-179-90	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A077470-001	RAMIPRIL	RAMIPRIL	1.25MG	CAPSULE / ORAL	2008-06-18
A077470-002	RAMIPRIL	RAMIPRIL	2.5MG	CAPSULE / ORAL	2008-06-18
A077470-003	RAMIPRIL	RAMIPRIL	5MG	CAPSULE / ORAL	2008-06-18
A077470-004	RAMIPRIL	RAMIPRIL	10MG	CAPSULE / ORAL	2008-06-18

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 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077470-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	2008-06-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077470-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	2008-06-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077470-003	RAMIPRIL	5MG	CAPSULE / ORAL	2008-06-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077470-004	RAMIPRIL	10MG	CAPSULE / ORAL	2008-06-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077470-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	2008-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077470-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	2008-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077470-003	RAMIPRIL	5MG	CAPSULE / ORAL	2008-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077470-004	RAMIPRIL	10MG	CAPSULE / ORAL	2008-06-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077470-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	2008-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077470-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	2008-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077470-003	RAMIPRIL	5MG	CAPSULE / ORAL	2008-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077470-004	RAMIPRIL	10MG	CAPSULE / ORAL	2008-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077470-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	2008-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077470-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	2008-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077470-003	RAMIPRIL	5MG	CAPSULE / ORAL	2008-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077470-004	RAMIPRIL	10MG	CAPSULE / ORAL	2008-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077470-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	2008-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077470-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	2008-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077470-003	RAMIPRIL	5MG	CAPSULE / ORAL	2008-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077470-004	RAMIPRIL	10MG	CAPSULE / ORAL	2008-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077470-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	2008-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077470-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	2008-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077470-003	RAMIPRIL	5MG	CAPSULE / ORAL	2008-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077470-004	RAMIPRIL	10MG	CAPSULE / ORAL	2008-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077470-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	2008-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077470-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	2008-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077470-003	RAMIPRIL	5MG	CAPSULE / ORAL	2008-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077470-004	RAMIPRIL	10MG	CAPSULE / ORAL	2008-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077470-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	2008-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077470-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	2008-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077470-003	RAMIPRIL	5MG	CAPSULE / ORAL	2008-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077470-004	RAMIPRIL	10MG	CAPSULE / ORAL	2008-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077470-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	2008-06-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077470-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	2008-06-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077470-003	RAMIPRIL	5MG	CAPSULE / ORAL	2008-06-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077470-004	RAMIPRIL	10MG	CAPSULE / ORAL	2008-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077470-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	2008-06-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077470-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	2008-06-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077470-003	RAMIPRIL	5MG	CAPSULE / ORAL	2008-06-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077470-004	RAMIPRIL	10MG	CAPSULE / ORAL	2008-06-18	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077470-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077470-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077470-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077470-004	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077470-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077470-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077470-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077470-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077470-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077470-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077470-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077470-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077470-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077470-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077470-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077470-004	AB	1	`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
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
9a7d2f1c-330a-4830-b88b-315f5c1bab6b	Product name	1	20151208
c76eceed-99b6-9572-9f36-9ac63b4b3ce4	Product name	2	20141218

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-179-90	2023-01-30	C162847	48780-1	f386c649-ed56-0266-e053-dadaa90a7c1a	RAMIPRIL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-179-90	RAMIPRIL	90 in 1 BOTTLE	CAPSULE	90		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RAMIPRIL	ACTIVE INGREDIENT	L35JN3I7SJ	RAMIPRIL CAPSULE [DIRECTRX]	1
RAMIPRILAT	ACTIVE MOIETY	6N5U4QFC3G	RAMIPRIL CAPSULE [DIRECTRX]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	RAMIPRIL CAPSULE [DIRECTRX]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	RAMIPRIL CAPSULE [DIRECTRX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	RAMIPRIL CAPSULE [DIRECTRX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	RAMIPRIL CAPSULE [DIRECTRX]	1
INDIGOTINDISULFONATE SODIUM	INACTIVE INGREDIENT	D3741U8K7L	RAMIPRIL CAPSULE [DIRECTRX]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	RAMIPRIL CAPSULE [DIRECTRX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	RAMIPRIL CAPSULE [DIRECTRX]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	RAMIPRIL CAPSULE [DIRECTRX]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	RAMIPRIL CAPSULE [DIRECTRX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RAMIPRIL CAPSULE [DIRECTRX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RAMIPRIL CAPSULE [DIRECTRX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-179	RAMIPRIL CAPSULE [DIRECTRX]	3	Legacy NDC, 1 package rows	20200122_01c74610-b705-4485-945b-e935090b6e68.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
261962	ramipril 10 MG Oral Capsule	PSN	01c74610-b705-4485-945b-e935090b6e68	3
261962	ramipril 10 MG Oral Capsule	SCD	01c74610-b705-4485-945b-e935090b6e68	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-179-90	61919017990	90 CAPSULE in 1 BOTTLE (61919-179-90)	90 capsule	2015-01-01	0000-00-00	No	No	Current