Ramipril

Product NDC
63629-7260
11-digit product format
636297260
Labeler code
63629
Product ID
63629-7260_5d42a08f-068a-41a5-90a9-0f1585eb5418
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091604
Marketing category
ANDA
Marketing start
2011-06-08
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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 · 5 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage63629-7260-1
excluded packagepackage63629-7260-3
excluded packagepackage63629-7260-4
excluded packagepackage63629-7260-2

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091604-001RAMIPRILRAMIPRIL1.25MGCAPSULE / ORALAB2011-06-08
A091604-002RAMIPRILRAMIPRIL2.5MGCAPSULE / ORALAB2011-06-08
A091604-003RAMIPRILRAMIPRIL5MGCAPSULE / ORALAB2011-06-08
A091604-004RAMIPRILRAMIPRIL10MGCAPSULE / ORALAB2011-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091604-001AB
A091604-002AB
A091604-003AB
A091604-004AB

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 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A091604-001RAMIPRIL1.25MGCAPSULE / ORALAB2011-06-08c2088c7a36db…
2026-10-15 13:18:302026-09A091604-002RAMIPRIL2.5MGCAPSULE / ORALAB2011-06-08c2088c7a36db…
2026-10-15 13:18:302026-09A091604-003RAMIPRIL5MGCAPSULE / ORALAB2011-06-08c2088c7a36db…
2026-10-15 13:18:302026-09A091604-004RAMIPRIL10MGCAPSULE / ORALAB2011-06-08c2088c7a36db…
2026-09-14 22:38:342026-08A091604-001RAMIPRIL1.25MGCAPSULE / ORALAB2011-06-0884e616aacf4f…
2026-09-14 22:38:342026-08A091604-002RAMIPRIL2.5MGCAPSULE / ORALAB2011-06-0884e616aacf4f…
2026-09-14 22:38:342026-08A091604-003RAMIPRIL5MGCAPSULE / ORALAB2011-06-0884e616aacf4f…
2026-09-14 22:38:342026-08A091604-004RAMIPRIL10MGCAPSULE / ORALAB2011-06-0884e616aacf4f…
2026-08-18 06:07:402026-07A091604-001RAMIPRIL1.25MGCAPSULE / ORALAB2011-06-08caaa826d4ba7…
2026-08-18 06:07:402026-07A091604-002RAMIPRIL2.5MGCAPSULE / ORALAB2011-06-08caaa826d4ba7…
2026-08-18 06:07:402026-07A091604-003RAMIPRIL5MGCAPSULE / ORALAB2011-06-08caaa826d4ba7…
2026-08-18 06:07:402026-07A091604-004RAMIPRIL10MGCAPSULE / ORALAB2011-06-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091604-001RAMIPRIL1.25MGCAPSULE / ORALAB2011-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091604-002RAMIPRIL2.5MGCAPSULE / ORALAB2011-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091604-003RAMIPRIL5MGCAPSULE / ORALAB2011-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091604-004RAMIPRIL10MGCAPSULE / ORALAB2011-06-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091604-001RAMIPRIL1.25MGCAPSULE / ORALAB2011-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091604-002RAMIPRIL2.5MGCAPSULE / ORALAB2011-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091604-003RAMIPRIL5MGCAPSULE / ORALAB2011-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091604-004RAMIPRIL10MGCAPSULE / ORALAB2011-06-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A091604-001RAMIPRIL1.25MGCAPSULE / ORALAB2011-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091604-002RAMIPRIL2.5MGCAPSULE / ORALAB2011-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091604-003RAMIPRIL5MGCAPSULE / ORALAB2011-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091604-004RAMIPRIL10MGCAPSULE / ORALAB2011-06-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091604-001RAMIPRIL1.25MGCAPSULE / ORALAB2011-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091604-002RAMIPRIL2.5MGCAPSULE / ORALAB2011-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091604-003RAMIPRIL5MGCAPSULE / ORALAB2011-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091604-004RAMIPRIL10MGCAPSULE / ORALAB2011-06-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091604-001RAMIPRIL1.25MGCAPSULE / ORALAB2011-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091604-002RAMIPRIL2.5MGCAPSULE / ORALAB2011-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091604-003RAMIPRIL5MGCAPSULE / ORALAB2011-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091604-004RAMIPRIL10MGCAPSULE / ORALAB2011-06-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091604-001RAMIPRIL1.25MGCAPSULE / ORALAB2011-06-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091604-002RAMIPRIL2.5MGCAPSULE / ORALAB2011-06-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091604-003RAMIPRIL5MGCAPSULE / ORALAB2011-06-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091604-004RAMIPRIL10MGCAPSULE / ORALAB2011-06-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091604-001RAMIPRIL1.25MGCAPSULE / ORALAB2011-06-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091604-002RAMIPRIL2.5MGCAPSULE / ORALAB2011-06-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091604-003RAMIPRIL5MGCAPSULE / ORALAB2011-06-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091604-004RAMIPRIL10MGCAPSULE / ORALAB2011-06-082680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A091604-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A091604-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A091604-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09A091604-004AB1c2088c7a36db…
2026-09-14 22:38:342026-08A091604-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A091604-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A091604-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A091604-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A091604-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091604-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091604-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091604-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091604-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091604-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091604-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091604-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091604-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091604-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091604-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091604-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091604-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091604-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091604-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091604-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091604-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091604-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091604-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091604-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091604-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091604-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091604-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091604-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091604-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091604-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091604-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091604-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091604-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091604-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091604-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091604-004AB12680178bc6a6…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-7260-12020-10-12These highlights do not include all the information needed to use RAMIPRIL CAPSULES safely and effectively. See full prescribing information for RAMIPRIL CAPSULES. RAMIPRIL capsules, for oral use Initial U.S. Approval: 1991
63629-7260-12020-10-12These highlights do not include all the information needed to use RAMIPRIL CAPSULES safely and effectively. See full prescribing information for RAMIPRIL CAPSULES. RAMIPRIL capsules, for oral use Initial U.S. Approval: 1991
63629-7260-22020-10-12These highlights do not include all the information needed to use RAMIPRIL CAPSULES safely and effectively. See full prescribing information for RAMIPRIL CAPSULES. RAMIPRIL capsules, for oral use Initial U.S. Approval: 1991
63629-7260-22020-10-12These highlights do not include all the information needed to use RAMIPRIL CAPSULES safely and effectively. See full prescribing information for RAMIPRIL CAPSULES. RAMIPRIL capsules, for oral use Initial U.S. Approval: 1991
63629-7260-32020-10-12These highlights do not include all the information needed to use RAMIPRIL CAPSULES safely and effectively. See full prescribing information for RAMIPRIL CAPSULES. RAMIPRIL capsules, for oral use Initial U.S. Approval: 1991
63629-7260-32020-10-12These highlights do not include all the information needed to use RAMIPRIL CAPSULES safely and effectively. See full prescribing information for RAMIPRIL CAPSULES. RAMIPRIL capsules, for oral use Initial U.S. Approval: 1991
63629-7260-42020-10-12These highlights do not include all the information needed to use RAMIPRIL CAPSULES safely and effectively. See full prescribing information for RAMIPRIL CAPSULES. RAMIPRIL capsules, for oral use Initial U.S. Approval: 1991
63629-7260-42020-10-12These highlights do not include all the information needed to use RAMIPRIL CAPSULES safely and effectively. See full prescribing information for RAMIPRIL CAPSULES. RAMIPRIL capsules, for oral use Initial U.S. Approval: 1991
63629-7260-12020-01-31These highlights do not include all the information needed to use RAMIPRIL CAPSULES safely and effectively. See full prescribing information for RAMIPRIL CAPSULES. RAMIPRIL capsules, for oral use Initial U.S. Approval: 1991
63629-7260-12020-01-31These highlights do not include all the information needed to use RAMIPRIL CAPSULES safely and effectively. See full prescribing information for RAMIPRIL CAPSULES. RAMIPRIL capsules, for oral use Initial U.S. Approval: 1991
63629-7260-22020-01-31These highlights do not include all the information needed to use RAMIPRIL CAPSULES safely and effectively. See full prescribing information for RAMIPRIL CAPSULES. RAMIPRIL capsules, for oral use Initial U.S. Approval: 1991
63629-7260-22020-01-31These highlights do not include all the information needed to use RAMIPRIL CAPSULES safely and effectively. See full prescribing information for RAMIPRIL CAPSULES. RAMIPRIL capsules, for oral use Initial U.S. Approval: 1991
63629-7260-32020-01-31These highlights do not include all the information needed to use RAMIPRIL CAPSULES safely and effectively. See full prescribing information for RAMIPRIL CAPSULES. RAMIPRIL capsules, for oral use Initial U.S. Approval: 1991
63629-7260-32020-01-31These highlights do not include all the information needed to use RAMIPRIL CAPSULES safely and effectively. See full prescribing information for RAMIPRIL CAPSULES. RAMIPRIL capsules, for oral use Initial U.S. Approval: 1991
63629-7260-42020-01-31These highlights do not include all the information needed to use RAMIPRIL CAPSULES safely and effectively. See full prescribing information for RAMIPRIL CAPSULES. RAMIPRIL capsules, for oral use Initial U.S. Approval: 1991
63629-7260-42020-01-31These highlights do not include all the information needed to use RAMIPRIL CAPSULES safely and effectively. See full prescribing information for RAMIPRIL CAPSULES. RAMIPRIL capsules, for oral use Initial U.S. Approval: 1991

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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RamiprilRAMIPRILProficient Rx LPd3513b8b-2d8a-456d-b942-a25ec1965b042019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091604
application number: ANDA091604