SHAROBEL

Product NDC
16714-441
11-digit product format
167140441
Labeler code
16714
Product ID
16714-441_bc5880ea-5359-4f40-a2e5-7af0b1131a9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norethindrone
Dosage form
KIT
Labeler
Northstar Rx LLC
Application
ANDA200961
Marketing category
ANDA
Marketing start
2013-09-13
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui198042, 748961, 1539955

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d39a542a-f5b0-4c2d-a820-0f5d39e6621fProduct name120250307
859c4b0b-8cba-4f41-9afe-cc181a01fb62Product name220240215
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0d9f32e2-f85b-4d63-9f04-b06059c34749Product name320230323
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
cec4644c-0fed-4608-a5ea-d3a1b1b6d697Product name220200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424Product name620200716
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
c21bcd2e-ecbd-48e6-ab68-12cc12256c0fProduct name220190213
c6636356-4ccb-40e9-a952-59eb1f2fc859Product name420180806
e042bc86-5d40-8945-82f8-de9dd95420ddProduct name620180606
390e6d23-3a11-4327-9294-c958a378baaeProduct name420180124
b651f154-0364-4007-9dc6-9d33036db1d7Product name420170808
3395ac9b-f30b-4991-80ba-fd5196be0214Product name320170802
a5e2d962-d98c-4fbf-8183-ffd42dd01e19Product name620170711
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
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-441-01SHAROBEL1 in 1 BLISTER PACKKIT19
16714-441-01SHAROBEL1 in 1 PACKETKIT19
16714-441-02SHAROBEL1 in 1 BLISTER PACKKIT19
16714-441-02SHAROBEL1 in 1 CARTONKIT19
16714-441-03SHAROBEL3 in 1 CARTONKIT39
16714-441-03SHAROBEL1 in 1 BLISTER PACKKIT19
16714-441-04SHAROBEL1 in 1 BLISTER PACKKIT19
16714-441-04SHAROBEL6 in 1 CARTONKIT69

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-441-01EA - Each16714-441e267ef02-ddf1-476b-a1fa-4db9d9daca1112014-09-03
16714-441-04EA - Each16714-4419e31dd64-e57f-458b-87f5-54980df8117d12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NORETHINDRONEACTIVE INGREDIENTT18F433X4SSHAROBEL (NORETHINDRONE) KIT [NORTHSTAR RX LLC]2
NORETHINDRONEACTIVE MOIETYT18F433X4SSHAROBEL (NORETHINDRONE) KIT [NORTHSTAR RX LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSHAROBEL (NORETHINDRONE) KIT [NORTHSTAR RX LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SHAROBEL (NORETHINDRONE) KIT [NORTHSTAR RX LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSHAROBEL (NORETHINDRONE) KIT [NORTHSTAR RX LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSHAROBEL (NORETHINDRONE) KIT [NORTHSTAR RX LLC]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62SHAROBEL (NORETHINDRONE) KIT [NORTHSTAR RX LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SHAROBEL (NORETHINDRONE) KIT [NORTHSTAR RX LLC]2
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PSHAROBEL (NORETHINDRONE) KIT [NORTHSTAR RX LLC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SHAROBEL (NORETHINDRONE) KIT [NORTHSTAR RX LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSHAROBEL (NORETHINDRONE) KIT [NORTHSTAR RX LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1USHAROBEL (NORETHINDRONE) KIT [NORTHSTAR RX LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSHAROBEL (NORETHINDRONE) KIT [NORTHSTAR RX LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-441SHAROBEL (NORETHINDRONE) KIT [NORTHSTAR RX LLC]8Current NDC, Legacy NDC, 8 package rows20230903_a96f5194-ad2a-4783-a9a9-22a288caff25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1539955{28 (norethindrone 0.35 MG Oral Tablet) } Pack [Sharobel 28 Day]BPCKa96f5194-ad2a-4783-a9a9-22a288caff259
748961{28 (norethindrone 0.35 MG Oral Tablet) } PackGPCKa96f5194-ad2a-4783-a9a9-22a288caff259
748961Noreth 0.35 MG (28) Oral Tablet 28 Day PackPSNa96f5194-ad2a-4783-a9a9-22a288caff259
198042norethindrone 0.35 MG Oral TabletPSNa96f5194-ad2a-4783-a9a9-22a288caff259
1539955Sharobel 28 Day PackPSNa96f5194-ad2a-4783-a9a9-22a288caff259
198042norethindrone 0.35 MG Oral TabletSCDa96f5194-ad2a-4783-a9a9-22a288caff259
1539955Sharobel 28 Day PackSYa96f5194-ad2a-4783-a9a9-22a288caff259

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-441-01167140441011 BLISTER PACK in 1 PACKET (16714-441-01) / 1 KIT in 1 BLISTER PACK1 blister pack2013-09-130000-00-00NoNoCurrent
16714-441-02167140441021 BLISTER PACK in 1 CARTON (16714-441-02) / 1 KIT in 1 BLISTER PACK1 blister pack2020-01-010000-00-00NoNoCurrent
16714-441-03167140441033 BLISTER PACK in 1 CARTON (16714-441-03) / 1 KIT in 1 BLISTER PACK3 blister pack2020-01-010000-00-00NoNoCurrent
16714-441-04167140441046 BLISTER PACK in 1 CARTON (16714-441-04) / 1 KIT in 1 BLISTER PACK6 blister pack2013-09-130000-00-00NoNoCurrent