Ramipril

Product NDC: 71335-9645
11-digit product format: 713359645
Labeler code: 71335
Product ID: 71335-9645_0114712a-1579-4fef-8290-3519d069c519
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ramipril
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA077626
Marketing category: ANDA
Marketing start: 2008-06-10
Substance: RAMIPRIL
Active strength: 5 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
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 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	RLD / RS	Approval date
A077626-001	RAMIPRIL	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB		2008-06-09
A077626-002	RAMIPRIL	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB		2008-06-09
A077626-003	RAMIPRIL	RAMIPRIL	5MG	CAPSULE / ORAL	AB		2008-06-09
A077626-004	RAMIPRIL	RAMIPRIL	10MG	CAPSULE / ORAL	AB	RS	2008-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077626-001	AB
A077626-002	AB
A077626-003	AB
A077626-004	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077626-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB		2008-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077626-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB		2008-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077626-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB		2008-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077626-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	RS	2008-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077626-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB		2008-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077626-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB		2008-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077626-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB		2008-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077626-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	RS	2008-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077626-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB		2008-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077626-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB		2008-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077626-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB		2008-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077626-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	RS	2008-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077626-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB		2008-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077626-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB		2008-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077626-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB		2008-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077626-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB		2008-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077626-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB		2008-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077626-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB		2008-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077626-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB		2008-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077626-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB		2008-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077626-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB		2008-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077626-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB		2008-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077626-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB		2008-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077626-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB		2008-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077626-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB		2008-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077626-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB		2008-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077626-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB		2008-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077626-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB		2008-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077626-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB		2008-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077626-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB		2008-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077626-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB		2008-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077626-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB		2008-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077626-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB		2008-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077626-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB		2008-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077626-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB		2008-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077626-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB		2008-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077626-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB		2008-06-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077626-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB		2008-06-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077626-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB		2008-06-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077626-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB		2008-06-09	`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	A077626-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077626-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077626-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077626-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077626-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077626-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077626-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077626-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077626-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077626-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077626-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077626-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077626-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077626-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077626-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077626-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077626-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077626-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077626-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077626-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077626-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077626-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077626-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077626-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077626-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077626-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077626-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077626-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077626-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077626-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077626-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077626-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077626-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077626-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077626-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077626-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077626-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077626-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077626-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077626-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ramipril
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RAMIPRIL	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L35JN3I7SJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198189	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
3806abdc-6aec-4252-bd79-e2c115b849aa	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-9645-1	Ramipril	30 in 1 BOTTLE	CAPSULE	30	103
71335-9645-2	Ramipril	20 in 1 BOTTLE	CAPSULE	20	103
71335-9645-3	Ramipril	90 in 1 BOTTLE	CAPSULE	90	103
71335-9645-4	Ramipril	60 in 1 BOTTLE	CAPSULE	60	103
71335-9645-5	Ramipril	10 in 1 BOTTLE	CAPSULE	10	103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-9645	RAMIPRIL CAPSULE [BRYANT RANCH PREPACK]	102	Current NDC, 5 package rows	20240407_3806abdc-6aec-4252-bd79-e2c115b849aa.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ramipril	RAMIPRIL	Bryant Ranch Prepack	3806abdc-6aec-4252-bd79-e2c115b849aa	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077626 application number: ANDA077626 ndc (product): 71335-9645
Ramipril	RAMIPRIL	Lupin Pharmaceuticals, Inc.	a8cdec12-81d1-4ef4-82c0-d05d93c37a07	2026-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077626 application number: ANDA077626
Ramipril	RAMIPRIL	Northwind Health Company, LLC	ab3124b7-deed-8e04-e053-2a95a90a3b85	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077626 application number: ANDA077626
Ramipril	RAMIPRIL	Northwind Health Company, LLC	ab09a67e-18fe-c860-e053-2a95a90a4d03	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077626 application number: ANDA077626
Ramipril	RAMIPRIL	Northwind Health Company, LLC	ab324cb3-2aaa-b57f-e053-2995a90a2055	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077626 application number: ANDA077626
Ramipril	RAMIPRIL	A-S Medication Solutions	5fb23b7d-ed2b-4984-89c8-d0a509b917e1	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077626 application number: ANDA077626
Ramipril	RAMIPRIL	Proficient Rx LP	01da05d8-e72e-4208-bf92-a5cd929f15ab	2022-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077626 application number: ANDA077626

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
198189	ramipril 5 MG Oral Capsule	PSN	3806abdc-6aec-4252-bd79-e2c115b849aa	103
198189	ramipril 5 MG Oral Capsule	SCD	3806abdc-6aec-4252-bd79-e2c115b849aa	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-9645-1	71335964501	30 CAPSULE in 1 BOTTLE (71335-9645-1)	30 capsule	2023-04-18	No	No	Current
71335-9645-2	71335964502	20 CAPSULE in 1 BOTTLE (71335-9645-2)	20 capsule	2026-04-15	No	No	Current
71335-9645-3	71335964503	90 CAPSULE in 1 BOTTLE (71335-9645-3)	90 capsule	2026-04-15	No	No	Current
71335-9645-4	71335964504	60 CAPSULE in 1 BOTTLE (71335-9645-4)	60 capsule	2026-04-15	No	No	Current
71335-9645-5	71335964505	10 CAPSULE in 1 BOTTLE (71335-9645-5)	10 capsule	2026-04-15	No	No	Current