FDA.reportPublic FDA data

Estarylla

Product NDC
0781-4058
11-digit product format
007814058
Labeler code
0781
Product ID
0781-4058_13f99f65-1c63-a7fd-3bfa-de2b5ee2891e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norgestimate and ethinyl estradiol
Dosage form
KIT
Labeler
Sandoz Inc
Application
ANDA090794
Marketing category
ANDA
Marketing start
2013-02-01
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct0781-4058DDiscontinued by firm2026-07-31
excluded packagepackage0781-40580781-4058-15DDiscontinued 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
A090794-001ESTARYLLAETHINYL ESTRADIOL; NORGESTIMATE0.035MG;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
A090794-001AB

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 22:54:322026-06A090794-001ESTARYLLA0.035MG;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 22:54:322026-06A090794-001AB1a50c72e98297…

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
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP7acde5ef-f457-4c47-897b-d048194c7d7e2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090794
application number: ANDA090794
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepacke0b07fb6-8dbd-4e5d-b589-5191a1dc02ae2024-09-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090794
application number: ANDA090794
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLAvKAREa3c0c983-7ec7-244a-e053-2995a90adbe42024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090794
application number: ANDA090794
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLXiromed, LLC.7a4d2d7b-b97e-3e18-3d97-1e2579c8f3f82023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090794
application number: ANDA090794

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-4058-15EA - Each0781-4058f7cd72fc-95ef-4e72-a4d5-b3d1127bb92b12013-04-01