FDA.reportPublic FDA data

Tri-Lo- Estarylla

Product NDC
0781-4062
11-digit product format
007814062
Labeler code
0781
Product ID
0781-4062_09688713-1ca7-e96d-9d8b-96541a58a494
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norgestimate and ethinyl estradiol
Dosage form
KIT
Labeler
Sandoz Inc
Application
ANDA091232
Marketing category
ANDA
Marketing start
2015-11-25
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 productproduct0781-4062DDiscontinued by firm2026-07-31
excluded packagepackage0781-40620781-4062-15DDiscontinued 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
A091232-001TRI-LO-ESTARYLLAETHINYL ESTRADIOL; NORGESTIMATE0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-28AB2015-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091232-001AB

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 22:54:322026-06A091232-001TRI-LO-ESTARYLLA0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-28AB2015-06-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091232-001AB1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tri-Lo- EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepack90f7ab24-7839-4408-9a74-07bb6a79eacc2024-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091232
application number: ANDA091232
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLAvKAREa3ce752d-58df-363d-e053-2a95a90a54112024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091232
application number: ANDA091232
Tri-Lo- EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLXiromed, LLC.8381db98-f9b2-e894-c07e-5d49f10e4eea2023-12-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091232
application number: ANDA091232

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-4062-15EA - Each0781-406284831438-9787-421d-b495-bf01fb7898ee12016-01-13