FDA.reportPublic FDA data

TARINA Fe 1/20

Product NDC
53002-1711
11-digit product format
530021711
Labeler code
53002
Product ID
53002-1711_52b601c3-31b9-448a-839f-db9de6730313
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norethindrone acetate and ethinyl estradiol
Dosage form
KIT
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA202772
Marketing category
ANDA
Marketing start
2014-09-15
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53002-1711DDiscontinued by firm2026-07-31
excluded packagepackage53002-171153002-1711-1DDiscontinued by firm2026-07-31
excluded packagepackage53002-171153002-1711-3DDiscontinued by firm2026-07-31
excluded packagepackage53002-171153002-1711-6DDiscontinued 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
A202772-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORETHINDRONE ACETATE0.02MG;1MGTABLET / ORAL-28AB2013-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202772-001AB

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 22:54:322026-06A202772-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL0.02MG;1MGTABLET / ORAL-28AB2013-11-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202772-001AB1a50c72e98297…

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
FEIRZA 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP, 1 MG/0.02 MG AND FERROUS FUMARATE TABLETS, 75 MGXiromed LLCf4d11840-0209-f2f2-698e-5ffb647884d82024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202772
application number: ANDA202772

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-1711-12020-12-15C16284748780-19d75b9d0-0c10-f424-e053-dadaa90a57ceTarina® Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets)
53002-1711-32020-12-15C16284748780-19d75b9d0-0c10-f424-e053-dadaa90a57ceTarina® Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets)
53002-1711-62020-12-15C16284748780-19d75b9d0-0c10-f424-e053-dadaa90a57ceTarina® Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets)
53002-1711-12020-01-31C16284748780-19d75b9d0-0c10-f424-e053-dadaa90a57ceTarina® Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets)
53002-1711-32020-01-31C16284748780-19d75b9d0-0c10-f424-e053-dadaa90a57ceTarina® Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets)
53002-1711-62020-01-31C16284748780-19d75b9d0-0c10-f424-e053-dadaa90a57ceTarina® Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets)