Ramipril

Product NDC: 68001-142
Requested package NDC: 68001-142-00
11-digit product format: 680010142
Labeler code: 68001
Product ID: 68001-142_c4f8ab80-6693-8a4d-e053-2a95a90ac3a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ramipril
Dosage form: CAPSULE
Route: ORAL
Labeler: BluePoint Laboratories
Application: ANDA078832
Marketing category: ANDA
Marketing start: 2014-01-01
Marketing end: 2021-09-30
Substance: RAMIPRIL
Active strength: 3 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68001-142	68001-142-00	D	Discontinued by firm		2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	Approval date
A078832-001	RAMIPRIL	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-09-02
A078832-002	RAMIPRIL	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-09-02
A078832-003	RAMIPRIL	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-09-02
A078832-004	RAMIPRIL	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-09-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A078832-001	AB
A078832-002	AB
A078832-003	AB
A078832-004	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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	A078832-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078832-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078832-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078832-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078832-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078832-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078832-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078832-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078832-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078832-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078832-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078832-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078832-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078832-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078832-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078832-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078832-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078832-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078832-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078832-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078832-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078832-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078832-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078832-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078832-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078832-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078832-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078832-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078832-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078832-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078832-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078832-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-09-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078832-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-09-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078832-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-09-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078832-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-09-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078832-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-09-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078832-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2008-09-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078832-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2008-09-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078832-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2008-09-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078832-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2008-09-02	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078832-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078832-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078832-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078832-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078832-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078832-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078832-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078832-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078832-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078832-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078832-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078832-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078832-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078832-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078832-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078832-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078832-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078832-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078832-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078832-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078832-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078832-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078832-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078832-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078832-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078832-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078832-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078832-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078832-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078832-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078832-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078832-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078832-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078832-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078832-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078832-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078832-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078832-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078832-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078832-004	AB	1	`d06236e962d9…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RAMIPRIL	ACTIVE INGREDIENT	L35JN3I7SJ	RAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]	4
RAMIPRILAT	ACTIVE MOIETY	6N5U4QFC3G	RAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]	4
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	RAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	RAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	RAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	RAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]	4
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	RAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	RAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	RAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RAMIPRIL CAPSULE [BLUEPOINT LABORATORIES]	4

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ramipril	RAMIPRIL	Zydus Pharmaceuticals USA Inc.	055bb582-67cd-425a-8823-d543c14305ce	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078832 application number: ANDA078832
Ramipril	RAMIPRIL	PD-Rx Pharmaceuticals, Inc.	6187971a-2756-4791-8801-211bec0a6718	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078832 application number: ANDA078832
Ramipril	RAMIPRIL	Zydus Lifesciences Limited	496b346b-ca79-4483-a950-bed9464e6a9d	2024-12-04		Exact identifier application applno (ANDA): 078832 application number: ANDA078832

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
68001-142-00	68001014200	100 CAPSULE in 1 BOTTLE (68001-142-00)	100 capsule	2014-01-01	2021-09-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ramipril	BluePoint Laboratories \| Zydus Pharmaceuticals (USA) Inc. \| Cadila Healthcare Limited	2021-06-29	HUMAN PRESCRIPTION DRUG LABEL	8
Ramipril	American Health Packaging	2020-09-25	HUMAN PRESCRIPTION DRUG LABEL	5