FDA.reportPublic FDA data

Larin Fe 1/20

Product NDC
16714-406
11-digit product format
167140406
Labeler code
16714
Product ID
16714-406_09cca9eb-091f-4261-8493-a6d70af1d03a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate
Dosage form
KIT
Labeler
Northstar Rx LLC
Application
ANDA091454
Marketing category
ANDA
Marketing start
2013-08-26
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Larin Fe 1/20
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui259176, 1358762, 1358763, 1440183

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
859c4b0b-8cba-4f41-9afe-cc181a01fb62Product name220240215
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
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
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
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
6dd982ab-2966-22ee-3b75-d225abb791aaProduct name520190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
c21bcd2e-ecbd-48e6-ab68-12cc12256c0fProduct name220190213
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
f6ac5560-6d3b-d281-41d2-adc50d283c20Product name320170228
120cc5ad-761c-444c-9e82-dec22f96dfe1Product name720161219
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
23ede539-308f-46e5-817b-41ef23af8d40Product name120150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4dProduct name120150930
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
16714-406-01Larin Fe 1/201 in 1 BLISTER PACKKIT19
16714-406-01Larin Fe 1/201 in 1 PACKETKIT19
16714-406-02Larin Fe 1/201 in 1 BLISTER PACKKIT19
16714-406-02Larin Fe 1/201 in 1 CARTONKIT19
16714-406-03Larin Fe 1/201 in 1 BLISTER PACKKIT19
16714-406-03Larin Fe 1/203 in 1 CARTONKIT39
16714-406-04Larin Fe 1/201 in 1 BLISTER PACKKIT19
16714-406-04Larin Fe 1/206 in 1 CARTONKIT69

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-406-01EA - Each16714-4067708e890-043a-403c-b0a0-ae3801ee08e312013-11-04
16714-406-04EA - Each16714-40676ab8992-e08a-440d-a450-488c2b44ea6012013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571ULARIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [NORTHSTAR RX LLC]2
NORETHINDRONE ACETATEACTIVE INGREDIENT9S44LIC7OJLARIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [NORTHSTAR RX LLC]2
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571ULARIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [NORTHSTAR RX LLC]2
NORETHINDRONEACTIVE MOIETYT18F433X4SLARIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [NORTHSTAR RX LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULARIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [NORTHSTAR RX LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLARIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [NORTHSTAR RX LLC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLARIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [NORTHSTAR RX LLC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLARIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [NORTHSTAR RX LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LARIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [NORTHSTAR RX LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLARIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [NORTHSTAR RX LLC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LARIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [NORTHSTAR RX LLC]2
FERROUS FUMARATEINACTIVE INGREDIENTR5L488RY0QLARIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [NORTHSTAR RX LLC]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PLARIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [NORTHSTAR RX LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLARIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [NORTHSTAR RX LLC]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62LARIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [NORTHSTAR RX LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LARIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [NORTHSTAR RX LLC]2
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PLARIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [NORTHSTAR RX LLC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LARIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [NORTHSTAR RX LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLARIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [NORTHSTAR RX LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1ULARIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [NORTHSTAR RX LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLARIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [NORTHSTAR RX LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-406LARIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [NORTHSTAR RX LLC]8Current NDC, Legacy NDC, 8 package rows20230905_e71741c8-10fa-4eee-b0da-e42af451222c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1440183{21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack [Larin Fe 1/20]BPCKe71741c8-10fa-4eee-b0da-e42af451222c9
1358763{21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } PackGPCKe71741c8-10fa-4eee-b0da-e42af451222c9
1358763Eth-estra-Noreth Ac 0.02-1 MG (21) Oral Tablet / Ferr fum 75 MG (7) Oral Tablet 28 Day PackPSNe71741c8-10fa-4eee-b0da-e42af451222c9
259176ferrous fumarate 75 MG Oral TabletPSNe71741c8-10fa-4eee-b0da-e42af451222c9
1440183LARIN Fe 1/20 28 Day PackPSNe71741c8-10fa-4eee-b0da-e42af451222c9
1358762norethindrone acetate 1 MG / ethinyl estradiol 0.02 MG Oral TabletPSNe71741c8-10fa-4eee-b0da-e42af451222c9
1358762ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral TabletSCDe71741c8-10fa-4eee-b0da-e42af451222c9
259176ferrous fumarate 75 MG Oral TabletSCDe71741c8-10fa-4eee-b0da-e42af451222c9
1358762ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Oral TabletSYe71741c8-10fa-4eee-b0da-e42af451222c9
1440183Larin Fe 1/20 28 Day PackSYe71741c8-10fa-4eee-b0da-e42af451222c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-406-01167140406011 BLISTER PACK in 1 PACKET (16714-406-01) / 1 KIT in 1 BLISTER PACK1 blister pack2013-08-260000-00-00NoNoCurrent
16714-406-02167140406021 BLISTER PACK in 1 CARTON (16714-406-02) / 1 KIT in 1 BLISTER PACK1 blister pack2013-08-260000-00-00NoNoCurrent
16714-406-03167140406033 BLISTER PACK in 1 CARTON (16714-406-03) / 1 KIT in 1 BLISTER PACK3 blister pack2013-08-260000-00-00NoNoCurrent
16714-406-04167140406046 BLISTER PACK in 1 CARTON (16714-406-04) / 1 KIT in 1 BLISTER PACK6 blister pack2013-08-260000-00-00NoNoCurrent