Ramipril

Product NDC
76282-672
11-digit product format
762820672
Labeler code
76282
Product ID
76282-672_37481fc5-771f-4dc7-aa06-6913ab75d485
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc.
Application
ANDA077900
Marketing category
ANDA
Marketing start
2008-06-18
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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077900-001RAMIPRILRAMIPRIL1.25MGCAPSULE / ORALAB2008-06-18
A077900-002RAMIPRILRAMIPRIL2.5MGCAPSULE / ORALAB2008-06-18
A077900-003RAMIPRILRAMIPRIL5MGCAPSULE / ORALAB2008-06-18
A077900-004RAMIPRILRAMIPRIL10MGCAPSULE / ORALAB2008-06-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077900-001AB
A077900-002AB
A077900-003AB
A077900-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077900-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077900-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077900-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077900-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077900-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077900-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077900-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077900-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077900-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077900-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077900-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077900-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077900-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077900-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077900-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077900-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077900-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077900-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077900-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077900-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077900-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077900-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077900-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077900-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077900-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077900-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077900-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077900-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077900-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077900-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077900-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077900-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077900-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077900-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077900-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077900-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077900-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A077900-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A077900-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A077900-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-18d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077900-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077900-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077900-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077900-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077900-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077900-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077900-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077900-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077900-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077900-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077900-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077900-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077900-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077900-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077900-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077900-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077900-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077900-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077900-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077900-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077900-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077900-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077900-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077900-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077900-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077900-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077900-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077900-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077900-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077900-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077900-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077900-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077900-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077900-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077900-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077900-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077900-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077900-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077900-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077900-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RAMIPRIL5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L35JN3I7SJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198188Internal RxNorm lookup
198189Internal RxNorm lookup
261962Internal RxNorm lookup
845488Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1e1dfacf-b831-4743-a874-9a5e5ef8a120Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9a7d2f1c-330a-4830-b88b-315f5c1bab6bProduct name120151208
c76eceed-99b6-9572-9f36-9ac63b4b3ce4Product name220141218

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-672-01Ramipril100 in 1 BOTTLECAPSULE1005
76282-672-05Ramipril500 in 1 BOTTLECAPSULE5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-672-01EA - Each76282-672a8962860-8243-4587-9faa-abcb8b0b0c7912020-05-08
76282-672-05EA - Each76282-6726f754d51-215e-4367-a3b9-bdb0d510dde812022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-672RAMIPRIL CAPSULE [EXELAN PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 2 package rows20220607_1e1dfacf-b831-4743-a874-9a5e5ef8a120.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RamiprilRAMIPRILHikma Pharmaceuticals USA Inc.7e9e84f7-ff47-463d-bf47-7a9745960aae2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077900
application number: ANDA077900
RamiprilRAMIPRILExelan Pharmaceuticals, Inc.1e1dfacf-b831-4743-a874-9a5e5ef8a1202021-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077900
application number: ANDA077900
ndc (product): 76282-672

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
845488ramipril 1.25 MG Oral CapsulePSN1e1dfacf-b831-4743-a874-9a5e5ef8a1205
261962ramipril 10 MG Oral CapsulePSN1e1dfacf-b831-4743-a874-9a5e5ef8a1205
198188ramipril 2.5 MG Oral CapsulePSN1e1dfacf-b831-4743-a874-9a5e5ef8a1205
198189ramipril 5 MG Oral CapsulePSN1e1dfacf-b831-4743-a874-9a5e5ef8a1205
845488ramipril 1.25 MG Oral CapsuleSCD1e1dfacf-b831-4743-a874-9a5e5ef8a1205
261962ramipril 10 MG Oral CapsuleSCD1e1dfacf-b831-4743-a874-9a5e5ef8a1205
198188ramipril 2.5 MG Oral CapsuleSCD1e1dfacf-b831-4743-a874-9a5e5ef8a1205
198189ramipril 5 MG Oral CapsuleSCD1e1dfacf-b831-4743-a874-9a5e5ef8a1205

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-672-0176282067201100 CAPSULE in 1 BOTTLE (76282-672-01) 100 capsule2020-01-280000-00-00NoNoCurrent
76282-672-0576282067205500 CAPSULE in 1 BOTTLE (76282-672-05) 500 capsule2021-10-280000-00-00NoNoCurrent