FDA.reportPublic FDA data

Mono-Linyah

Product NDC
16714-360
11-digit product format
167140360
Labeler code
16714
Product ID
16714-360_e9022492-18a7-44e1-9a89-45a4c06c72f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norgestimate and ethinyl estradiol
Dosage form
KIT
Labeler
Northstar Rx LLC
Application
ANDA090523
Marketing category
ANDA
Marketing start
2012-05-23
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui240128, 748797, 749860, 1365899

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
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
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
5e13e814-349e-3480-99f3-ee22a591426fProduct name220150518
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-360-01Mono-Linyah1 in 1 BLISTER PACKKIT19
16714-360-01Mono-Linyah1 in 1 PACKETKIT19
16714-360-02Mono-Linyah1 in 1 CARTONKIT19
16714-360-02Mono-Linyah1 in 1 BLISTER PACKKIT19
16714-360-03Mono-Linyah1 in 1 BLISTER PACKKIT19
16714-360-03Mono-Linyah3 in 1 CARTONKIT39
16714-360-04Mono-Linyah1 in 1 BLISTER PACKKIT19
16714-360-04Mono-Linyah6 in 1 CARTONKIT69

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-360-01EA - Each16714-360734e4ef8-970e-434a-bb43-7c5de42a81fc12013-05-02
16714-360-04EA - Each16714-360fde400a2-fcb0-4c88-89ba-a722fe479fde12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
NORGESTIMATEACTIVE INGREDIENTC291HFX4DYMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
NORGESTIMATEACTIVE MOIETYC291HFX4DYMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62MONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990MONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2
TRIACETININACTIVE INGREDIENTXHX3C3X673MONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-360MONO-LINYAH (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]9Current NDC, Legacy NDC, 8 package rows20250327_84a20017-344b-4684-a915-c85a55fcbbcb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1365899{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Mono-Linyah 28 Day]BPCK84a20017-344b-4684-a915-c85a55fcbbcb9
749860{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK84a20017-344b-4684-a915-c85a55fcbbcb9
749860Eth estra-Norgestim 0.035-0.25 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN84a20017-344b-4684-a915-c85a55fcbbcb9
748797inert 1 MG Oral TabletPSN84a20017-344b-4684-a915-c85a55fcbbcb9
1365899MONO-LINYAH 28 Day PackPSN84a20017-344b-4684-a915-c85a55fcbbcb9
240128norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral TabletPSN84a20017-344b-4684-a915-c85a55fcbbcb9
240128ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral TabletSCD84a20017-344b-4684-a915-c85a55fcbbcb9
748797inert ingredients 1 MG Oral TabletSCD84a20017-344b-4684-a915-c85a55fcbbcb9
240128ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral TabletSY84a20017-344b-4684-a915-c85a55fcbbcb9
1365899Mono-Linyah 28 Day PackSY84a20017-344b-4684-a915-c85a55fcbbcb9
1365899{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Mono-Linyah 28 Day]BPCK2ec8f18f-297c-405f-b191-a40767366bad6
749860{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK2ec8f18f-297c-405f-b191-a40767366bad6
749860Eth estra-Norgestim 0.035-0.25 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN2ec8f18f-297c-405f-b191-a40767366bad6
748797inert 1 MG Oral TabletPSN2ec8f18f-297c-405f-b191-a40767366bad6
1365899MONO-LINYAH 28 Day PackPSN2ec8f18f-297c-405f-b191-a40767366bad6
240128norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral TabletPSN2ec8f18f-297c-405f-b191-a40767366bad6
240128ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral TabletSCD2ec8f18f-297c-405f-b191-a40767366bad6
748797inert ingredients 1 MG Oral TabletSCD2ec8f18f-297c-405f-b191-a40767366bad6
240128ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral TabletSY2ec8f18f-297c-405f-b191-a40767366bad6
1365899Mono-Linyah 28 Day PackSY2ec8f18f-297c-405f-b191-a40767366bad6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-360-01167140360011 BLISTER PACK in 1 PACKET (16714-360-01) / 1 KIT in 1 BLISTER PACK1 blister pack2012-05-230000-00-00NoNoCurrent
16714-360-02167140360021 BLISTER PACK in 1 CARTON (16714-360-02) / 1 KIT in 1 BLISTER PACK1 blister pack2012-05-230000-00-00NoNoCurrent
16714-360-03167140360033 BLISTER PACK in 1 CARTON (16714-360-03) / 1 KIT in 1 BLISTER PACK3 blister pack2012-05-230000-00-00NoNoCurrent
16714-360-04167140360046 BLISTER PACK in 1 CARTON (16714-360-04) / 1 KIT in 1 BLISTER PACK6 blister pack2012-05-230000-00-00NoNoCurrent