Home NDC 50742-659 Dolishale
Product NDC 50742-659
11-digit product format 507420659
Labeler code 50742
Product ID 50742-659_514dd27c-d315-4775-91d2-a58ac2293edc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levonorgestrel and Ethinyl Estradiol
Dosage form TABLET
Route ORAL
Labeler Ingenus Pharmaceuticals, LLC
Application ANDA091692
Marketing category ANDA
Marketing start 2021-01-03
Substance LEVONORGESTREL; ETHINYL ESTRADIOL
Active strength 90; 20 ug/1; ug/1
Pharmacologic classes Estrogen Receptor Agonists [MoA], Estrogen [EPC], Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 A091692-001 DOLISHALE ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091692-001 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.
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 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A091692-001 DOLISHALE 0.02MG;0.09MG TABLET / ORAL AB 2020-10-22 a50c72e98297…
Observed Orange Book normalized TE history# 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 Dolishale
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVONORGESTREL 90 ug/1 ETHINYL ESTRADIOL 20 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5W7SIA7YZW Internal UNII lookup 423D2T571U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 722152 Internal RxNorm lookup 751553 Internal RxNorm lookup 2472307 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50742-659 DOLISHALE (LEVONORGESTREL AND ETHINYL ESTRADIOL) TABLET [INGENUS PHARMACEUTICALS, LLC] 2 Current NDC, Legacy NDC, 6 package rows 20250409_036a15be-8c2e-4f65-b5dc-f333e2994d4a.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 Dolishale LEVONORGESTREL AND ETHINYL ESTRADIOL Ingenus Pharmaceuticals, LLC 036a15be-8c2e-4f65-b5dc-f333e2994d4a 2025-04-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091692 application number: ANDA091692 ndc (product): 50742-659
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 50742-659-28 50742065928 1 BLISTER PACK in 1 CARTON (50742-659-28) / 28 TABLET in 1 BLISTER PACK 1 blister pack 2021-01-03 0000-00-00 No No Current 50742-659-68 50742065968 6 BLISTER PACK in 1 CARTON (50742-659-68) / 28 TABLET in 1 BLISTER PACK 6 blister pack 2021-01-03 0000-00-00 No No Current 50742-659-84 50742065984 3 BLISTER PACK in 1 CARTON (50742-659-84) / 28 TABLET in 1 BLISTER PACK 3 blister pack 2021-01-03 0000-00-00 No No Current