Ramipril

Product NDC: 63187-816
Requested package NDC: 63187-816-90
11-digit product format: 631870816
Labeler code: 63187
Product ID: 63187-816_cd41f0ae-d2bb-4ffc-9a5e-7ca6345cbe89
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ramipril
Dosage form: CAPSULE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA091604
Marketing category: ANDA
Marketing start: 2011-06-08
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: 2026-12-31
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	Approval date
A091604-001	RAMIPRIL	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08
A091604-002	RAMIPRIL	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08
A091604-003	RAMIPRIL	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08
A091604-004	RAMIPRIL	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091604-001	AB
A091604-002	AB
A091604-003	AB
A091604-004	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	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091604-001	RAMIPRIL	1.25MG	CAPSULE / ORAL	AB	2011-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091604-002	RAMIPRIL	2.5MG	CAPSULE / ORAL	AB	2011-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091604-003	RAMIPRIL	5MG	CAPSULE / ORAL	AB	2011-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091604-004	RAMIPRIL	10MG	CAPSULE / ORAL	AB	2011-06-08	`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	A091604-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091604-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091604-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091604-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091604-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091604-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091604-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091604-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091604-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091604-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091604-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091604-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091604-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091604-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091604-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091604-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091604-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091604-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091604-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091604-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091604-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091604-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ramipril
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RAMIPRIL	10 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
261962	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
afd766bc-2a42-40b5-b33f-1a8b5ce2622e	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
63187-816-30	Ramipril	30 in 1 BOTTLE	CAPSULE	30	3
63187-816-60	Ramipril	60 in 1 BOTTLE	CAPSULE	60	3
63187-816-90	Ramipril	90 in 1 BOTTLE	CAPSULE	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-816-30	EA - Each	63187-816	895df5e9-65d3-4be4-8b06-50fec9e3b9e1	1	2017-03-06
63187-816-90	EA - Each	63187-816	e54f88d4-a594-4cea-96a1-a4fb2ada3db0	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-816	RAMIPRIL CAPSULE [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 3 package rows	20191113_afd766bc-2a42-40b5-b33f-1a8b5ce2622e.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ramipril	RAMIPRIL	Aurobindo Pharma Limited	d6d57158-e8f9-4c91-8317-0374e0c87d33	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	Bryant Ranch Prepack	ef05b44e-4bf7-4afa-a5f6-06efa0d0abc3	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	Bryant Ranch Prepack	8be00433-3113-437e-8ab6-721af4d79185	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	Bryant Ranch Prepack	d270b634-0d6d-4614-b223-a2af1e238c2f	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	REMEDYREPACK INC.	f6c86139-b1f7-4e84-944f-94af883ce4ea	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	REMEDYREPACK INC.	fcf42121-8e85-4eae-82b4-bc029653b462	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	NuCare Pharmaceuticals, Inc.	4bd2d586-6851-4a40-e063-6394a90a0cab	2026-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	REMEDYREPACK INC.	394a49a8-81bb-43ba-8d6a-fa6fa5030587	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	A-S Medication Solutions	e8d9a115-71a7-4580-abbd-865e98b5d3f6	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	A-S Medication Solutions	d856fb57-f1a0-49e6-bb2d-b4924af48515	2026-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	A-S Medication Solutions	a3786664-a1b5-4914-99d6-79fb0e330e98	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	Northwind Health Company, LLC	f2b87655-93c3-16a5-e053-2a95a90a593c	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	Northwind Health Company, LLC	f2f325b8-f33d-3b93-e053-2995a90aa660	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	Northwind Health Company, LLC	f7e61b5b-fb5b-ba15-e053-6394a90adc3c	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	Northwind Health Company, LLC	fb0892da-3db7-3202-e053-6394a90ab605	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	Rising Pharma Holdings, Inc.	d5c58fb5-b415-4567-9790-55631705c5cd	2025-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	A-S Medication Solutions	1576188e-efd4-4e14-870e-fd9bd2751c45	2025-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	A-S Medication Solutions	dd3162eb-5f09-47ac-9efd-3ddeee695a25	2025-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	A-S Medication Solutions	4a91b706-c614-4472-92f2-4da5d7bdbf27	2024-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604
Ramipril	RAMIPRIL	Bryant Ranch Prepack	245d3580-77c6-4c0f-b324-c8514b792c59	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091604 application number: ANDA091604

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	afd766bc-2a42-40b5-b33f-1a8b5ce2622e	3
261962	ramipril 10 MG Oral Capsule	SCD	afd766bc-2a42-40b5-b33f-1a8b5ce2622e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-816-90	63187081690	90 CAPSULE in 1 BOTTLE (63187-816-90)	90 capsule	2017-02-01	0000-00-00	No	No	Current