Home NDC 16714-366 SETLAKIN
Product NDC 16714-366
11-digit product format 167140366
Labeler code 16714
Product ID 16714-366_f2cb2636-6eb7-4c73-add8-ebd8a18d158b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levonorgestrel and Ethinyl Estradiol
Dosage form KIT
Labeler Northstar Rx LLC
Application ANDA090716
Marketing category ANDA
Marketing start 2015-08-01
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 A090716-001 SETLAKIN ETHINYL ESTRADIOL; LEVONORGESTREL 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090716-001 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 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090716-001 SETLAKIN 0.03MG;0.15MG TABLET / ORAL AB 2014-09-15 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 SETLAKIN
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 238019 Internal RxNorm lookup 748797 Internal RxNorm lookup 751901 Internal RxNorm lookup 1661092 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 16714-366-03 SETLAKIN 1 in 1 POUCH KIT 1 9 16714-366-03 SETLAKIN 3 in 1 CARTON KIT 3 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-366 SETLAKIN (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC] 8 Current NDC, Legacy NDC, 2 package rows 20231104_b7b8ae08-3fb0-4c6c-af02-89f0f6f40ffb.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 SETLAKIN LEVONORGESTREL AND ETHINYL ESTRADIOL Northstar Rx LLC b7b8ae08-3fb0-4c6c-af02-89f0f6f40ffb 2025-12-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090716 application number: ANDA090716 ndc (product): 16714-366
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 16714-366-03 16714036603 3 POUCH in 1 CARTON (16714-366-03) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK 3 pouch 2015-08-01 0000-00-00 No No Current