Ramipril

Product NDC
71335-0894
11-digit product format
713350894
Labeler code
71335
Product ID
71335-0894_01cb18cc-6c11-43b6-8ecf-a7f9a720d745
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
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-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 · 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 UTC2026-02A091604-001RAMIPRIL1.25MGCAPSULE / 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…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091604-001RAMIPRIL1.25MGCAPSULE / ORALAB2011-06-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091604-002RAMIPRIL2.5MGCAPSULE / ORALAB2011-06-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091604-003RAMIPRIL5MGCAPSULE / ORALAB2011-06-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091604-004RAMIPRIL10MGCAPSULE / ORALAB2011-06-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091604-001RAMIPRIL1.25MGCAPSULE / ORALAB2011-06-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091604-002RAMIPRIL2.5MGCAPSULE / ORALAB2011-06-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091604-003RAMIPRIL5MGCAPSULE / ORALAB2011-06-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091604-004RAMIPRIL10MGCAPSULE / ORALAB2011-06-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091604-001RAMIPRIL1.25MGCAPSULE / ORALAB2011-06-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A091604-002RAMIPRIL2.5MGCAPSULE / ORALAB2011-06-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A091604-003RAMIPRIL5MGCAPSULE / ORALAB2011-06-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A091604-004RAMIPRIL10MGCAPSULE / ORALAB2011-06-08d06236e962d9…

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 UTC2026-02A091604-001AB1011fe1cb6892…
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…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091604-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091604-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091604-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091604-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091604-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091604-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091604-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091604-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091604-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091604-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091604-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091604-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Ramipril
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RAMIPRIL10 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d270b634-0d6d-4614-b223-a2af1e238c2fAvailable 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
71335-0894-1Ramipril30 in 1 BOTTLECAPSULE306
71335-0894-2Ramipril100 in 1 BOTTLECAPSULE1006
71335-0894-3Ramipril60 in 1 BOTTLECAPSULE606
71335-0894-4Ramipril90 in 1 BOTTLECAPSULE906
71335-0894-5Ramipril120 in 1 BOTTLECAPSULE1206
71335-0894-6Ramipril10 in 1 BOTTLECAPSULE106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0894RAMIPRIL CAPSULE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 6 package rows20240601_d270b634-0d6d-4614-b223-a2af1e238c2f.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RamiprilRAMIPRILAurobindo Pharma Limitedd6d57158-e8f9-4c91-8317-0374e0c87d332026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091604
application number: ANDA091604
RamiprilRAMIPRILBryant Ranch Prepackef05b44e-4bf7-4afa-a5f6-06efa0d0abc32026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091604
application number: ANDA091604
RamiprilRAMIPRILBryant Ranch Prepack8be00433-3113-437e-8ab6-721af4d791852026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091604
application number: ANDA091604
RamiprilRAMIPRILBryant Ranch Prepackd270b634-0d6d-4614-b223-a2af1e238c2f2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091604
application number: ANDA091604
ndc (product): 71335-0894
RamiprilRAMIPRILREMEDYREPACK INC.f6c86139-b1f7-4e84-944f-94af883ce4ea2026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091604
application number: ANDA091604
RamiprilRAMIPRILREMEDYREPACK INC.fcf42121-8e85-4eae-82b4-bc029653b4622026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091604
application number: ANDA091604
RamiprilRAMIPRILNuCare Pharmaceuticals, Inc.4bd2d586-6851-4a40-e063-6394a90a0cab2026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091604
application number: ANDA091604
RamiprilRAMIPRILREMEDYREPACK INC.394a49a8-81bb-43ba-8d6a-fa6fa50305872026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091604
application number: ANDA091604
RamiprilRAMIPRILA-S Medication Solutionse8d9a115-71a7-4580-abbd-865e98b5d3f62026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091604
application number: ANDA091604
RamiprilRAMIPRILA-S Medication Solutionsd856fb57-f1a0-49e6-bb2d-b4924af485152026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091604
application number: ANDA091604
RamiprilRAMIPRILA-S Medication Solutionsa3786664-a1b5-4914-99d6-79fb0e330e982026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091604
application number: ANDA091604
RamiprilRAMIPRILNorthwind Health Company, LLCf2b87655-93c3-16a5-e053-2a95a90a593c2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091604
application number: ANDA091604
RamiprilRAMIPRILNorthwind Health Company, LLCf2f325b8-f33d-3b93-e053-2995a90aa6602026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091604
application number: ANDA091604
RamiprilRAMIPRILNorthwind Health Company, LLCf7e61b5b-fb5b-ba15-e053-6394a90adc3c2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091604
application number: ANDA091604
RamiprilRAMIPRILNorthwind Health Company, LLCfb0892da-3db7-3202-e053-6394a90ab6052026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091604
application number: ANDA091604
RamiprilRAMIPRILRising Pharma Holdings, Inc.d5c58fb5-b415-4567-9790-55631705c5cd2025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091604
application number: ANDA091604
RamiprilRAMIPRILA-S Medication Solutions1576188e-efd4-4e14-870e-fd9bd2751c452025-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091604
application number: ANDA091604
RamiprilRAMIPRILA-S Medication Solutionsdd3162eb-5f09-47ac-9efd-3ddeee695a252025-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091604
application number: ANDA091604
RamiprilRAMIPRILA-S Medication Solutions4a91b706-c614-4472-92f2-4da5d7bdbf272024-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091604
application number: ANDA091604
RamiprilRAMIPRILBryant Ranch Prepack245d3580-77c6-4c0f-b324-c8514b792c592024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091604
application number: ANDA091604

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0894-17133508940130 CAPSULE in 1 BOTTLE (71335-0894-1) 30 capsule2019-02-220000-00-00NoNoCurrent
71335-0894-271335089402100 CAPSULE in 1 BOTTLE (71335-0894-2) 100 capsule2024-05-030000-00-00NoNoCurrent
71335-0894-37133508940360 CAPSULE in 1 BOTTLE (71335-0894-3) 60 capsule2024-05-290000-00-00NoNoCurrent
71335-0894-47133508940490 CAPSULE in 1 BOTTLE (71335-0894-4) 90 capsule2018-07-030000-00-00NoNoCurrent
71335-0894-571335089405120 CAPSULE in 1 BOTTLE (71335-0894-5) 120 capsule2024-05-290000-00-00NoNoCurrent
71335-0894-67133508940610 CAPSULE in 1 BOTTLE (71335-0894-6) 10 capsule2024-05-290000-00-00NoNoCurrent