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 1 .
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 · 41 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 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…2022-09-29 23:25 UTC 2022-09 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203163-001 ASHLYNA 0.03MG,0.01MG;0.15MG,N/A TABLET / ORAL AB 2015-02-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 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
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
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