ALTACE

Product NDC
61570-120
Requested package NDC
61570-120-01
11-digit product format
615700120
Labeler code
61570
Product ID
61570-120_7c58ba31-97ac-4b94-93c7-d6c9868df832
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ramipril
Dosage form
CAPSULE
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA019901
Marketing category
NDA
Marketing start
1991-01-28
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61570-12061570-120-01DDiscontinued by firm2026-08-11

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61570-12061570-120-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
N019901-001ALTACERAMIPRIL1.25MGCAPSULE / ORALRLD1991-01-28
N019901-002ALTACERAMIPRIL2.5MGCAPSULE / ORALRLD1991-01-28
N019901-003ALTACERAMIPRIL5MGCAPSULE / ORALRLD1991-01-28
N019901-004ALTACERAMIPRIL10MGCAPSULE / ORALRLD1991-01-28

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 UTC2026-02N019901-001ALTACE1.25MGCAPSULE / ORALRLD1991-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019901-002ALTACE2.5MGCAPSULE / ORALRLD1991-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019901-003ALTACE5MGCAPSULE / ORALRLD1991-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019901-004ALTACE10MGCAPSULE / ORALRLD1991-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019901-001ALTACE1.25MGCAPSULE / ORALRLD1991-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019901-002ALTACE2.5MGCAPSULE / ORALRLD1991-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019901-003ALTACE5MGCAPSULE / ORALRLD1991-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019901-004ALTACE10MGCAPSULE / ORALRLD1991-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N019901-001ALTACE1.25MGCAPSULE / ORALRLD1991-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019901-002ALTACE2.5MGCAPSULE / ORALRLD1991-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019901-003ALTACE5MGCAPSULE / ORALRLD1991-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019901-004ALTACE10MGCAPSULE / ORALRLD1991-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019901-001ALTACE1.25MGCAPSULE / ORALABRLD1991-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019901-002ALTACE2.5MGCAPSULE / ORALABRLD1991-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019901-003ALTACE5MGCAPSULE / ORALABRLD1991-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019901-004ALTACE10MGCAPSULE / ORALABRLD, RS1991-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019901-001ALTACE1.25MGCAPSULE / ORALABRLD1991-01-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019901-002ALTACE2.5MGCAPSULE / ORALABRLD1991-01-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019901-003ALTACE5MGCAPSULE / ORALABRLD1991-01-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019901-004ALTACE10MGCAPSULE / ORALABRLD, RS1991-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019901-001ALTACE1.25MGCAPSULE / ORALABRLD1991-01-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019901-002ALTACE2.5MGCAPSULE / ORALABRLD1991-01-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019901-003ALTACE5MGCAPSULE / ORALABRLD1991-01-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019901-004ALTACE10MGCAPSULE / ORALABRLD, RS1991-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019901-001ALTACE1.25MGCAPSULE / ORALABRLD1991-01-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019901-002ALTACE2.5MGCAPSULE / ORALABRLD1991-01-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019901-003ALTACE5MGCAPSULE / ORALABRLD1991-01-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019901-004ALTACE10MGCAPSULE / ORALABRLD, RS1991-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019901-001ALTACE1.25MGCAPSULE / ORALABRLD1991-01-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019901-002ALTACE2.5MGCAPSULE / ORALABRLD1991-01-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019901-003ALTACE5MGCAPSULE / ORALABRLD1991-01-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019901-004ALTACE10MGCAPSULE / ORALABRLD, RS1991-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019901-001ALTACE1.25MGCAPSULE / ORALABRLD1991-01-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019901-002ALTACE2.5MGCAPSULE / ORALABRLD1991-01-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019901-003ALTACE5MGCAPSULE / ORALABRLD1991-01-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019901-004ALTACE10MGCAPSULE / ORALABRLD, RS1991-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019901-001ALTACE1.25MGCAPSULE / ORALABRLD1991-01-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N019901-002ALTACE2.5MGCAPSULE / ORALABRLD1991-01-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N019901-003ALTACE5MGCAPSULE / ORALABRLD1991-01-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N019901-004ALTACE10MGCAPSULE / ORALABRLD, RS1991-01-28d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019901-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019901-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019901-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019901-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019901-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019901-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019901-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019901-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019901-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019901-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019901-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019901-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019901-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019901-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019901-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019901-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019901-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019901-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019901-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019901-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019901-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019901-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019901-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019901-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019901-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019901-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019901-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019901-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019901-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019901-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019901-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019901-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019901-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019901-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019901-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019901-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019901-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019901-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019901-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019901-004AB11e350fbaab3a…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N019901-00173684692020-08-30U-87174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019901-00273684692020-08-30U-87174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019901-00373684692020-08-30U-87174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019901-00473684692020-08-30U-87174a2ff9319b5…
2020-12-22 03:56 UTC2020-12N019901-00173684692020-08-30U-8718869cabd3fbd…
2020-12-22 03:56 UTC2020-12N019901-00273684692020-08-30U-8718869cabd3fbd…
2020-12-22 03:56 UTC2020-12N019901-00373684692020-08-30U-8718869cabd3fbd…
2020-12-22 03:56 UTC2020-12N019901-00473684692020-08-30U-8718869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019901-00173684692020-08-30U-871c0c555d07b60…
2020-11-12 02:37 UTC2020-11N019901-00273684692020-08-30U-871c0c555d07b60…
2020-11-12 02:37 UTC2020-11N019901-00373684692020-08-30U-871c0c555d07b60…
2020-11-12 02:37 UTC2020-11N019901-00473684692020-08-30U-871c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019901-00173684692020-08-30U-8713f01610625f2…
2019-12-14 00:12 UTC2019-12N019901-00273684692020-08-30U-8713f01610625f2…
2019-12-14 00:12 UTC2019-12N019901-00373684692020-08-30U-8713f01610625f2…
2019-12-14 00:12 UTC2019-12N019901-00473684692020-08-30U-8713f01610625f2…
2019-09-15 20:21 UTC2019-09N019901-00173684692020-08-30U-871b00525d2431f…
2019-09-15 20:21 UTC2019-09N019901-00273684692020-08-30U-871b00525d2431f…
2019-09-15 20:21 UTC2019-09N019901-00373684692020-08-30U-871b00525d2431f…
2019-09-15 20:21 UTC2019-09N019901-00473684692020-08-30U-871b00525d2431f…
2019-07-19 19:46 UTC2019-07N019901-00173684692020-08-30U-871ea99ee380514…
2019-07-19 19:46 UTC2019-07N019901-00273684692020-08-30U-871ea99ee380514…
2019-07-19 19:46 UTC2019-07N019901-00373684692020-08-30U-871ea99ee380514…
2019-07-19 19:46 UTC2019-07N019901-00473684692020-08-30U-871ea99ee380514…

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61570-120-01EA - Each61570-1200fa47b73-c5a0-491b-a479-2c097ec9e2ad12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61570-120ALTACE (RAMIPRIL) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]27Legacy NDC20250109_0fc34cd8-86e6-4034-73bd-4263a68ba046.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61570-120-0161570012001100 CAPSULE in 1 BOTTLE (61570-120-01) 100 capsule1991-01-280000-00-00NoNoCurrent