FDA.reportPublic FDA data

Tri-Previfem

Product NDC
0254-2030
11-digit product format
002542030
Labeler code
0254
Product ID
0254-2030_717f87bf-246e-4082-a79a-c1c5eb37a901
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norgestimate and ethinyl estradiol
Dosage form
KIT
Labeler
Par Pharmaceutical, Inc.
Application
ANDA090793
Marketing category
ANDA
Marketing start
2019-02-01
Marketing end
2022-03-31
Active strength
0
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0254-2030DDiscontinued by firm2026-07-31
excluded packagepackage0254-20300254-2030-80DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090793-001TRI-ESTARYLLAETHINYL ESTRADIOL; NORGESTIMATE0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-28AB2013-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090793-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090793-001TRI-ESTARYLLA0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-28AB2013-01-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090793-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tri-EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutionsf7f7c073-48e0-4065-970b-8103d76b6eb02026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090793
application number: ANDA090793
Tri-EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepack6560d15f-6ce9-4f0e-9b59-043dec35ddd92024-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090793
application number: ANDA090793
norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLAvKAREa3cfd79e-a344-1dfc-e053-2995a90a1ab72024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090793
application number: ANDA090793
Tri-EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLXiromed, LLC.1ba8a8ab-eb09-0807-47d4-6b4055d10d912023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090793
application number: ANDA090793

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0254-2030-80EA - Each0254-2030054d622d-0ba6-4f95-b9e2-483deccd8e3112019-02-13
0254-2030-91EA - Each0254-2030aa8fafd2-8e64-4798-b79b-6dfc8cc1157512019-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0254-2030-80002542030806 CARTON in 1 CARTON (0254-2030-80) > 1 BLISTER PACK in 1 CARTON (0254-2030-91) > 1 KIT in 1 BLISTER PACK6 carton2019-02-012022-03-31NoNoCurrent