FDA.reportPublic FDA data

Application 072695

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORTREL 0.5/35-28ETHINYL ESTRADIOL; NORETHINDRONETABLET;ORAL-280.035MG;0.5MGNoNo

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
A072695-001NORTREL 0.5/35-28ETHINYL ESTRADIOL; NORETHINDRONE0.035MG;0.5MGTABLET / ORAL-28AB1992-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A072695-001AB

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 22:54:322026-06A072695-001NORTREL 0.5/35-280.035MG;0.5MGTABLET / ORAL-28AB1992-02-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A072695-001AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nortrel 28 DayNORETHINDRONE AND ETHINYL ESTRADIOLA-S Medication Solutions33b895e4-b467-41b1-a812-8068cc5bb93e2024-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072695
application number: ANDA072695
ndc (product): 50090-3229
Nortrel 28 DayNORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.140c50d6-c931-423a-9aa0-526eae7ab93c2021-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072695
application number: ANDA072695
ndc (product): 0555-9008

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-9008NortrelNorethindrone and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9008NortrelNorethindrone and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9008NortrelNorethindrone and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9008NortrelNorethindrone and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9008NortrelNorethindrone and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-9008NortrelNorethindrone and Ethinyl EstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
50090-3229NortrelNorethindrone and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
51862-318NeconNorethindrone and Ethinyl EstradiolMayne Pharma Inc.ANDACurrent
51862-318NeconNorethindrone and Ethinyl EstradiolMayne Pharma Inc.ANDACurrent
51862-318NeconNorethindrone and Ethinyl EstradiolMayne Pharma Inc.ANDACurrent