Home NDC 68180-827-73 Fyavolv
Product NDC 68180-827
Requested package NDC 68180-827-73
11-digit product format 681800827
Labeler code 68180
Product ID 68180-827_42e98704-dee2-481c-849b-e3d9439a7005
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norethindrone Acetate and Ethinyl Estradiol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA204213
Marketing category ANDA
Marketing start 2016-03-15
Substance ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Active strength .0025; .5 mg/1; mg/1
Pharmacologic classes Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204213-001 FYAVOLV ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 A204213-002 FYAVOLV ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.005MG;1MG TABLET / ORAL AB 2015-12-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204213-001 FYAVOLV 0.0025MG;0.5MG TABLET / ORAL AB 2015-12-10 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204213-002 FYAVOLV 0.005MG;1MG TABLET / ORAL AB 2015-12-10 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fyavolv
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETHINYL ESTRADIOL .0025 mg/1 NORETHINDRONE ACETATE .5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 423D2T571U Internal UNII lookup 9S44LIC7OJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1090992 Internal RxNorm lookup 1251323 Internal RxNorm lookup 1736654 Internal RxNorm lookup 1736656 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68180-827-09 Fyavolv 90 in 1 BOTTLE TABLET, FILM COATED 90 18 68180-827-13 Fyavolv 1 in 1 POUCH TABLET, FILM COATED 1 18 68180-827-13 Fyavolv 3 in 1 CARTON TABLET, FILM COATED 3 18 68180-827-73 Fyavolv 1 in 1 POUCH TABLET, FILM COATED 1 18 68180-827-73 Fyavolv 3 in 1 CARTON TABLET, FILM COATED 3 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-827 FYAVOLV (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 16 Current NDC, Legacy NDC, 5 package rows 20250524_772c86d7-10a4-48c5-8c19-f8aac68f5ab4.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68180-827-73 68180082773 3 POUCH in 1 CARTON (68180-827-73) / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK 3 pouch 2020-11-30 0000-00-00 No No Current