Home NDC 68462-318 VIORELE
Product NDC 68462-318
11-digit product format 684620318
Labeler code 68462
Product ID 68462-318_985b7e31-558c-4e49-b6ff-a0951bc4a947
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desogestrel and Ethinyl Estradiol and Ethinyl Estradiol
Dosage form KIT
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA091346
Marketing category ANDA
Marketing start 2012-04-04
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 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 A091346-001 VIORELE DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091346-001 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 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091346-001 VIORELE 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2012-04-02 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Additional Listing Data#
Finished product Yes
Brand name base VIORELE
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 248310 Internal RxNorm lookup 249357 Internal RxNorm lookup 748797 Internal RxNorm lookup 759743 Internal RxNorm lookup 1252016 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 68462-318-29 VIORELE 3 in 1 CARTON KIT 3 17 68462-318-84 VIORELE 1 in 1 BLISTER PACK KIT 1 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DESOGESTREL ACTIVE INGREDIENT 81K9V7M3A3 VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 6 ETHINYL ESTRADIOL ACTIVE INGREDIENT 423D2T571U VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 6 DESOGESTREL ACTIVE MOIETY 81K9V7M3A3 VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 6 ETHINYL ESTRADIOL ACTIVE MOIETY 423D2T571U VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 6 .ALPHA.-TOCOPHEROL INACTIVE INGREDIENT H4N855PNZ1 VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 6 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 6 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 6 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 6 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 6 LACTOSE INACTIVE INGREDIENT J2B2A4N98G VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 6 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 6 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 6 STARCH, POTATO INACTIVE INGREDIENT 8I089SAH3T VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 6 TALC INACTIVE INGREDIENT 7SEV7J4R1U VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-318 VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 16 Current NDC, Legacy NDC, 2 package rows 20240706_39988aa6-8f68-40e8-9bdd-c40a3bdaad61.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 · 2 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VIORELE DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL A-S Medication Solutions 6422dcc3-959a-4590-9ca8-9dcb58e68253 2026-06-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091346 application number: ANDA091346 VIORELE DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL Glenmark Pharmaceuticals Inc., USA 39988aa6-8f68-40e8-9bdd-c40a3bdaad61 2026-01-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091346 application number: ANDA091346 ndc (product): 68462-318
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 68462-318-29 68462031829 3 BLISTER PACK in 1 CARTON (68462-318-29) / 1 KIT in 1 BLISTER PACK (68462-318-84) 3 blister pack 2012-04-04 0000-00-00 No No Current 68462-318-84 68462031884 1 in 1 BLISTER PACK Historical