FDA.reportPublic FDA data

Norgestimate and Ethinyl Estradiol

Product NDC
17478-260
11-digit product format
174780260
Labeler code
17478
Product ID
17478-260_4abe9d31-c125-427d-b056-9bb321eb19fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norgestimate and Ethinyl Estradiol
Dosage form
KIT
Route
ORAL
Labeler
Akorn
Application
ANDA200384
Marketing category
ANDA
Marketing start
2016-11-15
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct17478-260DDiscontinued by firm2026-07-31
excluded packagepackage17478-26017478-260-06DDiscontinued 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
A200384-001NORGESTIMATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORGESTIMATE0.035MG;0.25MGTABLET / ORAL-28AB2015-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200384-001AB

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 22:54:322026-06A200384-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2015-04-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A200384-001AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLNaari Pte Limited03de435b-b8fb-4faa-a0ec-01e48b5aaae42024-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200384
application number: ANDA200384

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-260-06EA - Each17478-2603ab9c6f3-b9ce-4c87-a3c4-915fbac151da12017-03-06
17478-260-28EA - Each17478-260ca7104f6-2878-4f9c-af5f-1c1c3913728512017-03-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17478-260-06174780260066 CARTON in 1 CARTON (17478-260-06) > 1 BLISTER PACK in 1 CARTON (17478-260-28) > 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK6 carton2016-11-150000-00-00NoNoCurrent