Home NDC 16714-809 New Day
Product NDC 16714-809
11-digit product format 167140809
Labeler code 16714
Product ID 16714-809_c8098a08-68ab-4487-9db1-aefc6322ed30
Type HUMAN OTC DRUG
Nonproprietary name levonorgestrel
Dosage form TABLET
Route ORAL
Labeler Northstar Rx LLC
Application ANDA207976
Marketing category ANDA
Marketing start 2016-03-11
Substance LEVONORGESTREL
Active strength 1.5 mg/1
Pharmacologic classes 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 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 A207976-001 HER STYLE LEVONORGESTREL 1.5MG TABLET / ORAL 2016-03-11
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 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207976-001 HER STYLE 1.5MG TABLET / ORAL 2016-03-11 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base New Day
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVONORGESTREL 1.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5W7SIA7YZW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 483325 Internal RxNorm lookup 2003710 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 16714-809-01 New Day 1 in 1 BLISTER PACK TABLET 1 7 16714-809-01 New Day 1 in 1 CARTON TABLET 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-809 NEW DAY (LEVONORGESTREL) TABLET [NORTHSTAR RX LLC] 6 Current NDC, Legacy NDC, 2 package rows 20231027_9e8c96f6-ab51-4721-b276-1ca02a712510.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.
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 16714-809-01 16714080901 1 BLISTER PACK in 1 CARTON (16714-809-01) / 1 TABLET in 1 BLISTER PACK 1 blister pack 2016-03-11 0000-00-00 No No Current