Ramipril

Product NDC
65862-475
11-digit product format
658620475
Labeler code
65862
Product ID
65862-475_b8cfe093-4dcc-4b8b-9c15-7bc70d7903cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA091604
Marketing category
ANDA
Marketing start
2011-06-08
Substance
RAMIPRIL
Active strength
2.5 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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct65862-475UNFINISHEDActive or certified unfinished drug listing2026-08-10
unfinished packagepackage65862-47565862-475-49UNFINISHEDActive or certified unfinished drug listing2026-08-10

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage65862-475-49a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage65862-475-491d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage65862-475-49390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage65862-475-49e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage65862-475-49bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage65862-475-49f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage65862-475-49f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage65862-475-4968b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage65862-475-4905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage65862-475-4948b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage65862-475-4927f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage65862-475-498d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage65862-475-49d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage65862-475-4950b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproduct906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage65862-475-49906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproduct6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage65862-475-496db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproduct8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage65862-475-498fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproduct4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage65862-475-494184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproduct4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage65862-475-494bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproduct263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage65862-475-49263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-30unfinished productproduct5b2001dcd8f5…54b53d4dc9e4…
2019-06-01 22:24 UTC · source 2019-05-30unfinished packagepackage65862-475-495b2001dcd8f5…54b53d4dc9e4…

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
RAMIPRIL2.5 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
d6d57158-e8f9-4c91-8317-0374e0c87d33Available 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
65862-475-01Ramipril100 in 1 BOTTLECAPSULE10017
65862-475-05Ramipril500 in 1 BOTTLECAPSULE50017
65862-475-10Ramipril10 in 1 BLISTER PACKCAPSULE1017
65862-475-10Ramipril10 in 1 CARTONCAPSULE1017
65862-475-30Ramipril30 in 1 BOTTLECAPSULE3017
65862-475-99Ramipril1000 in 1 BOTTLECAPSULE100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-475-01EA - Each65862-47529f1117e-d8ff-4f26-af80-af8d62917c7512012-07-24
65862-475-05EA - Each65862-4751f3c4a25-3a36-403f-a258-f819e29e544812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RAMIPRILACTIVE INGREDIENTL35JN3I7SJRAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
RAMIPRILATACTIVE MOIETY6N5U4QFC3GRAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTRAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357RAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
GELATININACTIVE INGREDIENT2G86QN327LRAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
SHELLACINACTIVE INGREDIENT46N107B71ORAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-475RAMIPRIL CAPSULE [AUROBINDO PHARMA LIMITED]17Current NDC, Legacy NDC, 6 package rows20240426_d6d57158-e8f9-4c91-8317-0374e0c87d33.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
ndc (product): 65862-475
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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
845488ramipril 1.25 MG Oral CapsulePSNd6d57158-e8f9-4c91-8317-0374e0c87d3317
261962ramipril 10 MG Oral CapsulePSNd6d57158-e8f9-4c91-8317-0374e0c87d3317
198188ramipril 2.5 MG Oral CapsulePSNd6d57158-e8f9-4c91-8317-0374e0c87d3317
198189ramipril 5 MG Oral CapsulePSNd6d57158-e8f9-4c91-8317-0374e0c87d3317
845488ramipril 1.25 MG Oral CapsuleSCDd6d57158-e8f9-4c91-8317-0374e0c87d3317
261962ramipril 10 MG Oral CapsuleSCDd6d57158-e8f9-4c91-8317-0374e0c87d3317
198188ramipril 2.5 MG Oral CapsuleSCDd6d57158-e8f9-4c91-8317-0374e0c87d3317
198189ramipril 5 MG Oral CapsuleSCDd6d57158-e8f9-4c91-8317-0374e0c87d3317
198188ramipril 2.5 MG Oral CapsulePSN4a91b706-c614-4472-92f2-4da5d7bdbf277
198188ramipril 2.5 MG Oral CapsuleSCD4a91b706-c614-4472-92f2-4da5d7bdbf277
198188ramipril 2.5 MG Oral CapsulePSN33bdfe96-1b7a-4859-b1c9-ef94b8bb7a2a3
198188ramipril 2.5 MG Oral CapsuleSCD33bdfe96-1b7a-4859-b1c9-ef94b8bb7a2a3
198188ramipril 2.5 MG Oral CapsulePSNf7e61b5b-fb5b-ba15-e053-6394a90adc3c2
198188ramipril 2.5 MG Oral CapsuleSCDf7e61b5b-fb5b-ba15-e053-6394a90adc3c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-475-0165862047501100 CAPSULE in 1 BOTTLE (65862-475-01) 100 capsule2011-06-080000-00-00NoNoCurrent
65862-475-0565862047505500 CAPSULE in 1 BOTTLE (65862-475-05) 500 capsule2011-06-080000-00-00NoNoCurrent
65862-475-106586204751010 BLISTER PACK in 1 CARTON (65862-475-10) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2011-06-080000-00-00NoNoCurrent
65862-475-306586204753030 CAPSULE in 1 BOTTLE (65862-475-30) 30 capsule2011-06-080000-00-00NoNoCurrent
65862-475-49658620475494000 CAPSULE in 1 BAG (65862-475-49)4000 capsule08-JUN-11Current
65862-475-99658620475991000 CAPSULE in 1 BOTTLE (65862-475-99) 1000 capsule2011-06-080000-00-00NoNoCurrent