Home NDC 68462-646 Ashlyna
Product NDC 68462-646
11-digit product format 684620646
Labeler code 68462
Product ID 68462-646_8ba0405a-4148-4c5c-80f1-28c73ebb41a7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol
Dosage form KIT
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA203163
Marketing category ANDA
Marketing start 2015-02-23
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 A203163-001 ASHLYNA ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203163-001 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 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 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 Ashlyna
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 238019 Internal RxNorm lookup 248310 Internal RxNorm lookup 749761 Internal RxNorm lookup 1603861 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 68462-646-91 Ashlyna 1 in 1 BLISTER PACK KIT 1 10 68462-646-93 Ashlyna 1 in 1 POUCH KIT 1 10 68462-646-93 Ashlyna 2 in 1 CARTON KIT 2 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ETHINYL ESTRADIOL ACTIVE INGREDIENT 423D2T571U ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 1 LEVONORGESTREL ACTIVE INGREDIENT 5W7SIA7YZW ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 1 ETHINYL ESTRADIOL ACTIVE MOIETY 423D2T571U ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 1 LEVONORGESTREL ACTIVE MOIETY 5W7SIA7YZW ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 1 POLACRILIN POTASSIUM INACTIVE INGREDIENT 0BZ5A00FQU ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK GENERICS INC., USA] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-646 ASHLYNA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA] 9 Current NDC, Legacy NDC, 3 package rows 20230328_407a9f63-9abf-4886-864a-d3dd0e429762.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 Ashlyna LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL A-S Medication Solutions 2004a53d-3f62-4c33-813a-94b1567fe465 2026-06-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203163 application number: ANDA203163 Ashlyna LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL Glenmark Pharmaceuticals Inc., USA 407a9f63-9abf-4886-864a-d3dd0e429762 2026-01-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203163 application number: ANDA203163 ndc (product): 68462-646
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 68462-646-91 68462064691 1 in 1 BLISTER PACK Historical 68462-646-93 68462064693 2 POUCH in 1 CARTON (68462-646-93) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK (68462-646-91) 2 pouch 2015-02-23 0000-00-00 No No Current