Home NDC 68180-864 Blisovi 24 Fe
Product NDC 68180-864
11-digit product format 681800864
Labeler code 68180
Product ID 68180-864_934a273b-4e1e-4b97-972f-71cdf6be0e05
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name norethindrone acetate and ethinyl estradiol
Dosage form KIT
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA091398
Marketing category ANDA
Marketing start 2019-11-07
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68180-864-13 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68180-864-13 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68180-864-13 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68180-864-13 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68180-864-13 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68180-864-13 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68180-864-13 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68180-864-13 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68180-864-13 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68180-864-13 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68180-864-13 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68180-864-13 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091398-001 BLISOVI 24 FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET / ORAL AB 2015-10-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091398-001 AB
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 2 · 43 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 2026-09-14 22:38:34 2026-08 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091398-001 BLISOVI 24 FE 0.02MG;1MG TABLET / ORAL AB 2015-10-28 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Blisovi 24 Fe
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 259176 Internal RxNorm lookup 1358762 Internal RxNorm lookup 1359117 Internal RxNorm lookup 1722680 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 68180-864-73 Blisovi 24 Fe 1 in 1 BLISTER PACK KIT 1 8 68180-864-73 Blisovi 24 Fe 3 in 1 CARTON KIT 3 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ETHINYL ESTRADIOL ACTIVE INGREDIENT 423D2T571U BLISOVI 24 FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 4 NORETHINDRONE ACETATE ACTIVE INGREDIENT 9S44LIC7OJ BLISOVI 24 FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 4 ETHINYL ESTRADIOL ACTIVE MOIETY 423D2T571U BLISOVI 24 FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 4 NORETHINDRONE ACTIVE MOIETY T18F433X4S BLISOVI 24 FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 4 ACACIA INACTIVE INGREDIENT 5C5403N26O BLISOVI 24 FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BLISOVI 24 FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 4 FERROUS FUMARATE INACTIVE INGREDIENT R5L488RY0Q BLISOVI 24 FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X BLISOVI 24 FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BLISOVI 24 FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 4 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X BLISOVI 24 FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 4 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BLISOVI 24 FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BLISOVI 24 FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 4 SUCROSE INACTIVE INGREDIENT C151H8M554 BLISOVI 24 FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U BLISOVI 24 FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-864 BLISOVI 24 FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20250509_1183b048-16f3-47a4-a42f-22ba07b2bb52.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Blisovi 24 Fe NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL Lupin Pharmaceuticals, Inc. 1183b048-16f3-47a4-a42f-22ba07b2bb52 2025-11-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091398 application number: ANDA091398 ndc (product): 68180-864
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 68180-864-73 68180086473 3 BLISTER PACK in 1 CARTON (68180-864-73) / 1 KIT in 1 BLISTER PACK 3 blister pack 2019-11-07 0000-00-00 No No Current