FDA.reportPublic FDA data

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Product NDC
0378-7315
11-digit product format
003787315
Labeler code
0378
Product ID
0378-7315_bf48ffc9-4188-4415-a0de-dbc537f3b319
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norethindrone acetate and ethinyl estradiol and ferrous fumarate
Dosage form
KIT
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA206120
Marketing category
ANDA
Marketing start
2017-09-13
Marketing end
2019-06-30
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 productproduct0378-7315DDiscontinued by firm2026-07-31
excluded packagepackage0378-73150378-7315-53DDiscontinued 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
A206120-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEETHINYL ESTRADIOL; NORETHINDRONE ACETATE0.02MG;1MGTABLET / ORAL2017-09-12

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 22:54:322026-06A206120-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGTABLET / ORAL2017-09-12a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7315-53EA - Each0378-7315413510e1-f7b3-44b7-88a6-31dea661966f12017-10-13
0378-7315-85EA - Each0378-7315720811be-3d1f-4f37-917a-75e8319a9dca12017-10-13