Ramipril

Product NDC
68382-374
Requested package NDC
68382-374-77
11-digit product format
683820374
Labeler code
68382
Product ID
68382-374_0fcc9d88-ecff-40db-a5bf-870d917146ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA090697
Marketing category
ANDA
Marketing start
2017-12-05
Marketing end
0000-00-00
Substance
RAMIPRIL
Active strength
1 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68382-37468382-374-77DDiscontinued by firm2026-10-15

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-37468382-374-77DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-37468382-374-77DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
A090697-001RAMIPRILRAMIPRIL1.25MGTABLET / ORAL2009-09-24
A090697-002RAMIPRILRAMIPRIL2.5MGTABLET / ORAL2009-09-24
A090697-003RAMIPRILRAMIPRIL5MGTABLET / ORAL2009-09-24
A090697-004RAMIPRILRAMIPRIL10MGTABLET / ORAL2009-09-24

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 13:18:302026-09A090697-001RAMIPRIL1.25MGTABLET / ORAL2009-09-24c2088c7a36db…
2026-10-15 13:18:302026-09A090697-002RAMIPRIL2.5MGTABLET / ORAL2009-09-24c2088c7a36db…
2026-10-15 13:18:302026-09A090697-003RAMIPRIL5MGTABLET / ORAL2009-09-24c2088c7a36db…
2026-10-15 13:18:302026-09A090697-004RAMIPRIL10MGTABLET / ORAL2009-09-24c2088c7a36db…
2026-09-14 22:38:342026-08A090697-001RAMIPRIL1.25MGTABLET / ORAL2009-09-2484e616aacf4f…
2026-09-14 22:38:342026-08A090697-002RAMIPRIL2.5MGTABLET / ORAL2009-09-2484e616aacf4f…
2026-09-14 22:38:342026-08A090697-003RAMIPRIL5MGTABLET / ORAL2009-09-2484e616aacf4f…
2026-09-14 22:38:342026-08A090697-004RAMIPRIL10MGTABLET / ORAL2009-09-2484e616aacf4f…
2026-08-18 06:07:402026-07A090697-001RAMIPRIL1.25MGTABLET / ORAL2009-09-24caaa826d4ba7…
2026-08-18 06:07:402026-07A090697-002RAMIPRIL2.5MGTABLET / ORAL2009-09-24caaa826d4ba7…
2026-08-18 06:07:402026-07A090697-003RAMIPRIL5MGTABLET / ORAL2009-09-24caaa826d4ba7…
2026-08-18 06:07:402026-07A090697-004RAMIPRIL10MGTABLET / ORAL2009-09-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090697-001RAMIPRIL1.25MGTABLET / ORAL2009-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090697-002RAMIPRIL2.5MGTABLET / ORAL2009-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090697-003RAMIPRIL5MGTABLET / ORAL2009-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090697-004RAMIPRIL10MGTABLET / ORAL2009-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090697-001RAMIPRIL1.25MGTABLET / ORAL2009-09-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090697-002RAMIPRIL2.5MGTABLET / ORAL2009-09-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090697-003RAMIPRIL5MGTABLET / ORAL2009-09-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090697-004RAMIPRIL10MGTABLET / ORAL2009-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A090697-001RAMIPRIL1.25MGTABLET / ORAL2009-09-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090697-002RAMIPRIL2.5MGTABLET / ORAL2009-09-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090697-003RAMIPRIL5MGTABLET / ORAL2009-09-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090697-004RAMIPRIL10MGTABLET / ORAL2009-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090697-001RAMIPRIL1.25MGTABLET / ORAL2009-09-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090697-002RAMIPRIL2.5MGTABLET / ORAL2009-09-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090697-003RAMIPRIL5MGTABLET / ORAL2009-09-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090697-004RAMIPRIL10MGTABLET / ORAL2009-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090697-001RAMIPRIL1.25MGTABLET / ORAL2009-09-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090697-002RAMIPRIL2.5MGTABLET / ORAL2009-09-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090697-003RAMIPRIL5MGTABLET / ORAL2009-09-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090697-004RAMIPRIL10MGTABLET / ORAL2009-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090697-001RAMIPRIL1.25MGTABLET / ORAL2009-09-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090697-002RAMIPRIL2.5MGTABLET / ORAL2009-09-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090697-003RAMIPRIL5MGTABLET / ORAL2009-09-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090697-004RAMIPRIL10MGTABLET / ORAL2009-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090697-001RAMIPRIL1.25MGTABLET / ORAL2009-09-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090697-002RAMIPRIL2.5MGTABLET / ORAL2009-09-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090697-003RAMIPRIL5MGTABLET / ORAL2009-09-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090697-004RAMIPRIL10MGTABLET / ORAL2009-09-242680178bc6a6…

Reported adverse events (FAERS/openFDA)#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-374-776838203747710 BLISTER PACK in 1 CARTON (68382-374-77) > 10 TABLET in 1 BLISTER PACK10 blister pack2017-12-050000-00-00NoNoCurrent