FDA.reportPublic FDA data

Levonest

Product NDC
16714-340
11-digit product format
167140340
Labeler code
16714
Product ID
16714-340_8057bfb7-5eeb-404f-9614-4e629c2d1f4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levonorgestrel and ethinyl estradiol
Dosage form
KIT
Labeler
Northstar Rx LLC
Application
ANDA090719
Marketing category
ANDA
Marketing start
2010-12-29
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levonest
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui310230, 348804, 348805, 748797, 748832, 1095227

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1ecea64-06d1-4fdc-a2a1-b801e0cd0d11Product name420250623
d39a542a-f5b0-4c2d-a820-0f5d39e6621fProduct name120250307
8511fc19-172b-4e1f-90ec-2f09c85b16deProduct name220250116
d9a998ac-31a9-4391-9054-c30e50912603Product name220240829
782f1593-b73e-4d35-8017-647969d714d8Product name420240805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
1a545a57-aed5-4b6e-b1f9-a93c26d50effProduct name120230829
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50Product name320230718
a057e1a7-94b1-4663-8d17-a3bbf3a12689Product name520230627
0d9f32e2-f85b-4d63-9f04-b06059c34749Product name320230323
fa479cfe-0bd0-7366-d57a-92f3682e87c5Product name320210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9Product name320210513
cec4644c-0fed-4608-a5ea-d3a1b1b6d697Product name220200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424Product name620200716
5956a0e2-c373-452c-bdcf-c93d354432efProduct name120200714
ca306105-d51c-4821-9ec1-8eec753d073dProduct name120200619
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9Product name820200612
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6Product name820191120
6dd982ab-2966-22ee-3b75-d225abb791aaProduct name520190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
f713a022-3e1c-4035-bc91-62131bc80b42Product name220190125
60ff9adc-7870-42ca-8836-514bd9732fa8Product name420181220
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
c6636356-4ccb-40e9-a952-59eb1f2fc859Product name420180806
79d5025d-8129-440a-b861-6df2d2661609Product name320180607
e042bc86-5d40-8945-82f8-de9dd95420ddProduct name620180606
d871c48c-6b0b-4203-b55d-72ead21ea7adProduct name520180419
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
390e6d23-3a11-4327-9294-c958a378baaeProduct name420180124
12434b90-2738-45d5-9e1b-55001e853273Product name220171122
b651f154-0364-4007-9dc6-9d33036db1d7Product name420170808
3395ac9b-f30b-4991-80ba-fd5196be0214Product name320170802
2d386545-84d1-e1e9-1402-7fc8962353e8Product name220170717
a5e2d962-d98c-4fbf-8183-ffd42dd01e19Product name620170711
30783b73-16b0-4cc1-b03a-e5d801c0d7a8Product name420170608
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
00606b81-6e33-4c38-9ca9-bd14bd74d84cProduct name420170501
f4ce24e8-8632-4fad-9984-b693f985f80fProduct name320170501
b17c5419-b38b-579f-10bc-8a4ce69fc044Product name520170316
120cc5ad-761c-444c-9e82-dec22f96dfe1Product name720161219
741e98f2-ac6c-4d80-9ca8-c663c171ba1dProduct name120161121
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
cc765024-f257-4c67-b780-c356aadd6980Product name320150902
5e13e814-349e-3480-99f3-ee22a591426fProduct name220150518
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5a9b579b-8431-5b3a-2ba4-86556704f873Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
d03a75af-b11b-673b-268b-318050d0b3bdProduct name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
e5ccd419-1745-560a-1e25-c6e3941c710aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-340-01Levonest1 in 1 BLISTER PACKKIT19
16714-340-01Levonest1 in 1 PACKETKIT19
16714-340-02Levonest1 in 1 CARTONKIT19
16714-340-02Levonest1 in 1 BLISTER PACKKIT19
16714-340-03Levonest1 in 1 BLISTER PACKKIT19
16714-340-03Levonest3 in 1 CARTONKIT39
16714-340-04Levonest6 in 1 CARTONKIT69
16714-340-04Levonest1 in 1 BLISTER PACKKIT19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-340-01EA - Each16714-340ff07fd27-b68d-4d87-b3e6-0d44a8564bab12013-02-13
16714-340-04EA - Each16714-340d80ba8ff-502f-44e4-9d7e-a7d354790a2312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571ULEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWLEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571ULEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWLEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MLEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62LEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IELEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
POLYETHYLENE GLYCOL 3000INACTIVE INGREDIENTSA1B764746LEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PLEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BLEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
TRIACETININACTIVE INGREDIENTXHX3C3X673LEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-340LEVONEST (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]8Current NDC, Legacy NDC, 8 package rows20231102_be7000f1-5bf1-4de5-a256-e4436c37f0a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1095227{6 (ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet) / 10 (ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet) / 5 (ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Levonest 28 Day]BPCKdfda3568-b626-4194-b0af-df5d2ea69e3f20
748832{6 (ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet) / 10 (ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet) / 5 (ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCKdfda3568-b626-4194-b0af-df5d2ea69e3f20
748832Eth estra-Levonorgest 0.03-0.05 MG (6) Oral Tablet / Eth estra-Levonorgest 0.03-0.125 MG (10) Oral Tablet / Eth estra-Levonorgest 0.04-0.075 MG (5) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSNdfda3568-b626-4194-b0af-df5d2ea69e3f20
310230ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral TabletPSNdfda3568-b626-4194-b0af-df5d2ea69e3f20
348804ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral TabletPSNdfda3568-b626-4194-b0af-df5d2ea69e3f20
348805ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral TabletPSNdfda3568-b626-4194-b0af-df5d2ea69e3f20
748797inert 1 MG Oral TabletPSNdfda3568-b626-4194-b0af-df5d2ea69e3f20
1095227LEVONEST 28 Day Triphasic PackPSNdfda3568-b626-4194-b0af-df5d2ea69e3f20
310230ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral TabletSCDdfda3568-b626-4194-b0af-df5d2ea69e3f20
348804ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral TabletSCDdfda3568-b626-4194-b0af-df5d2ea69e3f20
348805ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral TabletSCDdfda3568-b626-4194-b0af-df5d2ea69e3f20
748797inert ingredients 1 MG Oral TabletSCDdfda3568-b626-4194-b0af-df5d2ea69e3f20
348804ethinyl estradiol 30 MCG / levonorgestrel 125 MCG Oral TabletSYdfda3568-b626-4194-b0af-df5d2ea69e3f20
348805ethinyl estradiol 40 MCG / levonorgestrel 75 MCG Oral TabletSYdfda3568-b626-4194-b0af-df5d2ea69e3f20
1095227Levonest 28 Day PackSYdfda3568-b626-4194-b0af-df5d2ea69e3f20
1095227{6 (ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet) / 10 (ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet) / 5 (ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Levonest 28 Day]BPCKbe7000f1-5bf1-4de5-a256-e4436c37f0a19
748832{6 (ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral Tablet) / 10 (ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral Tablet) / 5 (ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCKbe7000f1-5bf1-4de5-a256-e4436c37f0a19
748832Eth estra-Levonorgest 0.03-0.05 MG (6) Oral Tablet / Eth estra-Levonorgest 0.03-0.125 MG (10) Oral Tablet / Eth estra-Levonorgest 0.04-0.075 MG (5) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSNbe7000f1-5bf1-4de5-a256-e4436c37f0a19
310230ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral TabletPSNbe7000f1-5bf1-4de5-a256-e4436c37f0a19
348804ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral TabletPSNbe7000f1-5bf1-4de5-a256-e4436c37f0a19
348805ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral TabletPSNbe7000f1-5bf1-4de5-a256-e4436c37f0a19
748797inert 1 MG Oral TabletPSNbe7000f1-5bf1-4de5-a256-e4436c37f0a19
1095227LEVONEST 28 Day Triphasic PackPSNbe7000f1-5bf1-4de5-a256-e4436c37f0a19
310230ethinyl estradiol 0.03 MG / levonorgestrel 0.05 MG Oral TabletSCDbe7000f1-5bf1-4de5-a256-e4436c37f0a19
348804ethinyl estradiol 0.03 MG / levonorgestrel 0.125 MG Oral TabletSCDbe7000f1-5bf1-4de5-a256-e4436c37f0a19
348805ethinyl estradiol 0.04 MG / levonorgestrel 0.075 MG Oral TabletSCDbe7000f1-5bf1-4de5-a256-e4436c37f0a19
748797inert ingredients 1 MG Oral TabletSCDbe7000f1-5bf1-4de5-a256-e4436c37f0a19
348804ethinyl estradiol 30 MCG / levonorgestrel 125 MCG Oral TabletSYbe7000f1-5bf1-4de5-a256-e4436c37f0a19
348805ethinyl estradiol 40 MCG / levonorgestrel 75 MCG Oral TabletSYbe7000f1-5bf1-4de5-a256-e4436c37f0a19
1095227Levonest 28 Day PackSYbe7000f1-5bf1-4de5-a256-e4436c37f0a19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-340-01167140340011 BLISTER PACK in 1 PACKET (16714-340-01) / 1 KIT in 1 BLISTER PACK1 blister pack2010-12-290000-00-00NoNoCurrent
16714-340-02167140340021 BLISTER PACK in 1 CARTON (16714-340-02) / 1 KIT in 1 BLISTER PACK1 blister pack2010-12-290000-00-00NoNoCurrent
16714-340-03167140340033 BLISTER PACK in 1 CARTON (16714-340-03) / 1 KIT in 1 BLISTER PACK3 blister pack2010-12-290000-00-00NoNoCurrent
16714-340-04167140340046 BLISTER PACK in 1 CARTON (16714-340-04) / 1 KIT in 1 BLISTER PACK6 blister pack2010-12-290000-00-00NoNoCurrent