Ramipril

Product NDC
62135-274
11-digit product format
621350274
Labeler code
62135
Product ID
62135-274_47ce17ad-f085-8ce7-e063-6294a90a7520
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
Chartwell RX, LLC.
Application
ANDA078745
Marketing category
ANDA
Marketing start
2020-08-26
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
2027-12-31
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
A078745-001RAMIPRILRAMIPRIL1.25MGCAPSULE / ORALAB2008-06-18
A078745-002RAMIPRILRAMIPRIL2.5MGCAPSULE / ORALAB2008-06-18
A078745-003RAMIPRILRAMIPRIL5MGCAPSULE / ORALAB2008-06-18
A078745-004RAMIPRILRAMIPRIL10MGCAPSULE / 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
A078745-001AB
A078745-002AB
A078745-003AB
A078745-004AB

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 UTC2026-02A078745-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078745-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078745-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078745-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078745-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078745-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078745-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078745-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078745-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078745-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078745-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078745-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078745-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078745-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078745-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078745-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078745-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078745-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078745-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078745-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078745-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078745-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078745-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078745-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078745-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078745-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078745-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078745-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078745-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078745-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078745-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078745-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078745-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078745-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078745-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078745-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078745-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A078745-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A078745-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A078745-004RAMIPRIL10MGCAPSULE / 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 UTC2026-02A078745-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078745-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078745-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078745-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078745-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078745-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078745-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078745-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078745-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078745-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078745-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078745-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078745-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078745-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078745-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078745-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078745-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078745-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078745-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078745-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078745-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078745-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078745-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078745-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078745-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078745-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078745-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078745-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078745-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078745-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078745-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078745-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078745-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078745-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078745-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078745-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078745-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078745-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078745-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078745-004AB1d06236e962d9…

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 · 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
b7e49f05-6d4f-465a-b0d7-f704466a2e52Available 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
62135-274-01Ramipril100 in 1 BOTTLECAPSULE1004
62135-274-05Ramipril500 in 1 BOTTLECAPSULE5004
62135-274-90Ramipril90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-274-01EA - Each62135-274cdb976dc-85ee-4905-be81-f5ea3db52a5812020-09-14
62135-274-05EA - Each62135-2742040012c-43de-49d8-aef5-81b977152a8312020-09-14
62135-274-90EA - Each62135-274804999f4-76ce-4475-8a86-82a3cc4b3a0712026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-274RAMIPRIL CAPSULE [CHARTWELL RX, LLC.]3Current NDC, Legacy NDC, 3 package rows20231104_b7e49f05-6d4f-465a-b0d7-f704466a2e52.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RamiprilRAMIPRILChartwell RX, LLC.b7e49f05-6d4f-465a-b0d7-f704466a2e522026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078745
application number: ANDA078745
ndc (product): 62135-274

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
845488ramipril 1.25 MG Oral CapsulePSNb7e49f05-6d4f-465a-b0d7-f704466a2e524
261962ramipril 10 MG Oral CapsulePSNb7e49f05-6d4f-465a-b0d7-f704466a2e524
198188ramipril 2.5 MG Oral CapsulePSNb7e49f05-6d4f-465a-b0d7-f704466a2e524
198189ramipril 5 MG Oral CapsulePSNb7e49f05-6d4f-465a-b0d7-f704466a2e524
845488ramipril 1.25 MG Oral CapsuleSCDb7e49f05-6d4f-465a-b0d7-f704466a2e524
261962ramipril 10 MG Oral CapsuleSCDb7e49f05-6d4f-465a-b0d7-f704466a2e524
198188ramipril 2.5 MG Oral CapsuleSCDb7e49f05-6d4f-465a-b0d7-f704466a2e524
198189ramipril 5 MG Oral CapsuleSCDb7e49f05-6d4f-465a-b0d7-f704466a2e524

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-274-0162135027401100 CAPSULE in 1 BOTTLE (62135-274-01) 100 capsule2020-08-260000-00-00NoNoCurrent
62135-274-0562135027405500 CAPSULE in 1 BOTTLE (62135-274-05) 500 capsule2020-08-260000-00-00NoNoCurrent
62135-274-906213502749090 CAPSULE in 1 BOTTLE (62135-274-90) 90 capsule2026-01-02NoNoCurrent