Home NDC 16714-359 Falmina
Product NDC 16714-359
11-digit product format 167140359
Labeler code 16714
Product ID 16714-359_a0973aa1-ac56-4811-8221-cdf0e79c3f90
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name levonorgestrel and ethinyl estradiol
Dosage form KIT
Labeler Northstar Rx LLC
Application ANDA090721
Marketing category ANDA
Marketing start 2013-09-13
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 A090721-001 FALMINA ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090721-001 AB1
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 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090721-001 FALMINA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2012-03-28 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 Falmina
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 242297 Internal RxNorm lookup 748797 Internal RxNorm lookup 748868 Internal RxNorm lookup 1304988 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-359 FALMINA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC] 8 Current NDC, Legacy NDC, 8 package rows 20250304_cf6f069e-4b78-4adb-b5be-100b9d85aab7.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 16714-359-01 16714035901 1 BLISTER PACK in 1 PACKET (16714-359-01) / 1 KIT in 1 BLISTER PACK 1 blister pack 2013-09-13 0000-00-00 No No Current 16714-359-02 16714035902 1 BLISTER PACK in 1 CARTON (16714-359-02) / 1 KIT in 1 BLISTER PACK 1 blister pack 2013-09-13 0000-00-00 No No Current 16714-359-03 16714035903 3 BLISTER PACK in 1 CARTON (16714-359-03) / 1 KIT in 1 BLISTER PACK 3 blister pack 2013-09-13 0000-00-00 No No Current 16714-359-04 16714035904 6 BLISTER PACK in 1 CARTON (16714-359-04) / 1 KIT in 1 BLISTER PACK 6 blister pack 2013-09-13 0000-00-00 No No Current