Ramipril

Product NDC
68180-591
11-digit product format
681800591
Labeler code
68180
Product ID
68180-591_c73b9a08-9128-464e-9a01-040977af1368
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA077626
Marketing category
ANDA
Marketing start
2008-06-10
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
A077626-001RAMIPRILRAMIPRIL1.25MGCAPSULE / ORALAB2008-06-09
A077626-002RAMIPRILRAMIPRIL2.5MGCAPSULE / ORALAB2008-06-09
A077626-003RAMIPRILRAMIPRIL5MGCAPSULE / ORALAB2008-06-09
A077626-004RAMIPRILRAMIPRIL10MGCAPSULE / ORALABRS2008-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077626-001AB
A077626-002AB
A077626-003AB
A077626-004AB

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 UTC2026-02A077626-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077626-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077626-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077626-004RAMIPRIL10MGCAPSULE / ORALABRS2008-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077626-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077626-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077626-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077626-004RAMIPRIL10MGCAPSULE / ORALABRS2008-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077626-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077626-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077626-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077626-004RAMIPRIL10MGCAPSULE / ORALABRS2008-06-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077626-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077626-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077626-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077626-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077626-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077626-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077626-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077626-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077626-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077626-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077626-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077626-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077626-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077626-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077626-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077626-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077626-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077626-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077626-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077626-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077626-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077626-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077626-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077626-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077626-001RAMIPRIL1.25MGCAPSULE / ORALAB2008-06-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A077626-002RAMIPRIL2.5MGCAPSULE / ORALAB2008-06-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A077626-003RAMIPRIL5MGCAPSULE / ORALAB2008-06-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A077626-004RAMIPRIL10MGCAPSULE / ORALAB2008-06-09d06236e962d9…

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 UTC2026-02A077626-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077626-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077626-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077626-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077626-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077626-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077626-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077626-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077626-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077626-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077626-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077626-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077626-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077626-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077626-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077626-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077626-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077626-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077626-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077626-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077626-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077626-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077626-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077626-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077626-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077626-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077626-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077626-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077626-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077626-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077626-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077626-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077626-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077626-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077626-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077626-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077626-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077626-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077626-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077626-004AB1d06236e962d9…

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
a8cdec12-81d1-4ef4-82c0-d05d93c37a07Available 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
68180-591-01Ramipril100 in 1 BOTTLECAPSULE10019
68180-591-02Ramipril500 in 1 BOTTLECAPSULE50019
68180-591-09Ramipril90 in 1 BOTTLECAPSULE9019
68180-591-10Ramipril90 in 1 BOTTLECAPSULE9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-591-01EA - Each68180-591a549410f-326e-4c0e-a143-fa4dc31c8ddb12012-07-24
68180-591-02EA - Each68180-591342f692b-c5ba-4a7f-b8e2-c568cfbca25112012-07-24
68180-591-09EA - Each68180-591bb090492-efda-412b-bd92-553bdde04c1612012-07-24
68180-591-10EA - Each68180-591ea3a7337-f1cd-437c-821e-48d7d5645ced12024-12-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RAMIPRILACTIVE INGREDIENTL35JN3I7SJRAMIPRIL CAPSULE [LUPIN PHARMACEUTICALS, INC.]5
RAMIPRILATACTIVE MOIETY6N5U4QFC3GRAMIPRIL CAPSULE [LUPIN PHARMACEUTICALS, INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRAMIPRIL CAPSULE [LUPIN PHARMACEUTICALS, INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRAMIPRIL CAPSULE [LUPIN PHARMACEUTICALS, INC.]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARAMIPRIL CAPSULE [LUPIN PHARMACEUTICALS, INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRAMIPRIL CAPSULE [LUPIN PHARMACEUTICALS, INC.]5
GELATININACTIVE INGREDIENT2G86QN327LRAMIPRIL CAPSULE [LUPIN PHARMACEUTICALS, INC.]5
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYRAMIPRIL CAPSULE [LUPIN PHARMACEUTICALS, INC.]5
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJRAMIPRIL CAPSULE [LUPIN PHARMACEUTICALS, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRAMIPRIL CAPSULE [LUPIN PHARMACEUTICALS, INC.]5
RAMIPRILACTIVE INGREDIENTL35JN3I7SJRAMIPRIL CAPSULE [PROFICIENT RX LP]3
RAMIPRILATACTIVE MOIETY6N5U4QFC3GRAMIPRIL CAPSULE [PROFICIENT RX LP]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRAMIPRIL CAPSULE [PROFICIENT RX LP]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRAMIPRIL CAPSULE [PROFICIENT RX LP]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARAMIPRIL CAPSULE [PROFICIENT RX LP]3
GELATININACTIVE INGREDIENT2G86QN327LRAMIPRIL CAPSULE [PROFICIENT RX LP]3
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYRAMIPRIL CAPSULE [PROFICIENT RX LP]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRAMIPRIL CAPSULE [PROFICIENT RX LP]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRAMIPRIL CAPSULE [PROFICIENT RX LP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-591RAMIPRIL CAPSULE [LUPIN PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 4 package rows20241206_a8cdec12-81d1-4ef4-82c0-d05d93c37a07.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RamiprilRAMIPRILBryant Ranch Prepack3806abdc-6aec-4252-bd79-e2c115b849aa2026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077626
application number: ANDA077626
RamiprilRAMIPRILLupin Pharmaceuticals, Inc.a8cdec12-81d1-4ef4-82c0-d05d93c37a072026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077626
application number: ANDA077626
ndc (product): 68180-591
RamiprilRAMIPRILNorthwind Health Company, LLCab3124b7-deed-8e04-e053-2a95a90a3b852026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077626
application number: ANDA077626
RamiprilRAMIPRILNorthwind Health Company, LLCab09a67e-18fe-c860-e053-2a95a90a4d032026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077626
application number: ANDA077626
RamiprilRAMIPRILNorthwind Health Company, LLCab324cb3-2aaa-b57f-e053-2995a90a20552026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077626
application number: ANDA077626
RamiprilRAMIPRILA-S Medication Solutions5fb23b7d-ed2b-4984-89c8-d0a509b917e12025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077626
application number: ANDA077626
RamiprilRAMIPRILProficient Rx LP01da05d8-e72e-4208-bf92-a5cd929f15ab2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077626
application number: ANDA077626

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
845488ramipril 1.25 MG Oral CapsulePSNa8cdec12-81d1-4ef4-82c0-d05d93c37a0719
261962ramipril 10 MG Oral CapsulePSNa8cdec12-81d1-4ef4-82c0-d05d93c37a0719
198188ramipril 2.5 MG Oral CapsulePSNa8cdec12-81d1-4ef4-82c0-d05d93c37a0719
198189ramipril 5 MG Oral CapsulePSNa8cdec12-81d1-4ef4-82c0-d05d93c37a0719
845488ramipril 1.25 MG Oral CapsuleSCDa8cdec12-81d1-4ef4-82c0-d05d93c37a0719
261962ramipril 10 MG Oral CapsuleSCDa8cdec12-81d1-4ef4-82c0-d05d93c37a0719
198188ramipril 2.5 MG Oral CapsuleSCDa8cdec12-81d1-4ef4-82c0-d05d93c37a0719
198189ramipril 5 MG Oral CapsuleSCDa8cdec12-81d1-4ef4-82c0-d05d93c37a0719
261962ramipril 10 MG Oral CapsulePSN01da05d8-e72e-4208-bf92-a5cd929f15ab6
198189ramipril 5 MG Oral CapsulePSN01da05d8-e72e-4208-bf92-a5cd929f15ab6
261962ramipril 10 MG Oral CapsuleSCD01da05d8-e72e-4208-bf92-a5cd929f15ab6
198189ramipril 5 MG Oral CapsuleSCD01da05d8-e72e-4208-bf92-a5cd929f15ab6
261962ramipril 10 MG Oral CapsulePSNab3124b7-deed-8e04-e053-2a95a90a3b855
261962ramipril 10 MG Oral CapsuleSCDab3124b7-deed-8e04-e053-2a95a90a3b855

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-591-0168180059101100 CAPSULE in 1 BOTTLE (68180-591-01) 100 capsule2024-11-250000-00-00NoNoCurrent
68180-591-0268180059102500 CAPSULE in 1 BOTTLE (68180-591-02) 500 capsule2024-11-250000-00-00NoNoCurrent
68180-591-096818005910990 CAPSULE in 1 BOTTLE (68180-591-09) 90 capsule2008-06-100000-00-00NoNoCurrent
68180-591-106818005911090 CAPSULE in 1 BOTTLE (68180-591-10) 90 capsule2024-12-10NoNoCurrent