Ramipril

Product NDC: 63187-073
Requested package NDC: 63187-073-90
11-digit product format: 631870073
Labeler code: 63187
Product ID: 63187-073_cada6f46-f67d-41d9-8dbe-53740c3dac62
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ramipril
Dosage form: CAPSULE
Route: ORAL
Labeler: Proficient Rx LP
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: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	63187-073	63187-073-90	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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: 2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198189	Internal RxNorm lookup
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
01da05d8-e72e-4208-bf92-a5cd929f15ab	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
63187-073-30	Ramipril	30 in 1 BOTTLE	CAPSULE	30	6
63187-073-60	Ramipril	60 in 1 BOTTLE	CAPSULE	60	6
63187-073-90	Ramipril	90 in 1 BOTTLE	CAPSULE	90	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RAMIPRIL	ACTIVE INGREDIENT	L35JN3I7SJ	RAMIPRIL CAPSULE [PROFICIENT RX LP]	3
RAMIPRILAT	ACTIVE MOIETY	6N5U4QFC3G	RAMIPRIL CAPSULE [PROFICIENT RX LP]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	RAMIPRIL CAPSULE [PROFICIENT RX LP]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	RAMIPRIL CAPSULE [PROFICIENT RX LP]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	RAMIPRIL CAPSULE [PROFICIENT RX LP]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	RAMIPRIL CAPSULE [PROFICIENT RX LP]	3
MEGLUMINE	INACTIVE INGREDIENT	6HG8UB2MUY	RAMIPRIL CAPSULE [PROFICIENT RX LP]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	RAMIPRIL CAPSULE [PROFICIENT RX LP]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RAMIPRIL CAPSULE [PROFICIENT RX LP]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-073	RAMIPRIL CAPSULE [PROFICIENT RX LP]	6	Current NDC, Legacy NDC, 3 package rows	20220730_01da05d8-e72e-4208-bf92-a5cd929f15ab.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
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 ndc (package): 63187-073-90 ndc (product): 63187-073 ndc11 (package): 63187007390

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	01da05d8-e72e-4208-bf92-a5cd929f15ab	6
198189	ramipril 5 MG Oral Capsule	PSN	01da05d8-e72e-4208-bf92-a5cd929f15ab	6
261962	ramipril 10 MG Oral Capsule	SCD	01da05d8-e72e-4208-bf92-a5cd929f15ab	6
198189	ramipril 5 MG Oral Capsule	SCD	01da05d8-e72e-4208-bf92-a5cd929f15ab	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-073-90	63187007390	90 CAPSULE in 1 BOTTLE (63187-073-90)	90 capsule	2014-06-01	0000-00-00	No	No	Current