DEBLITANE

Product NDC
16714-440
11-digit product format
167140440
Labeler code
16714
Product ID
16714-440_843ad7a1-bcee-4568-acd1-31673b04b913
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norethindrone
Dosage form
KIT
Labeler
Northstar Rx LLC
Application
ANDA202014
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
DEBLITANE
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui198042, 748961, 1539953

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
16714-440-01DEBLITANE1 in 1 BLISTER PACKKIT16
16714-440-01DEBLITANE1 in 1 PACKETKIT16
16714-440-02DEBLITANE1 in 1 CARTONKIT16
16714-440-02DEBLITANE1 in 1 BLISTER PACKKIT16
16714-440-03DEBLITANE3 in 1 CARTONKIT36
16714-440-03DEBLITANE1 in 1 BLISTER PACKKIT16
16714-440-04DEBLITANE6 in 1 CARTONKIT66
16714-440-04DEBLITANE1 in 1 BLISTER PACKKIT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-440-01EA - Each16714-440df41a315-0162-46a2-a150-6b77cd3728b312014-10-03
16714-440-04EA - Each16714-4408cafddb1-b903-48de-a5fc-3cbcb9911d2b12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NORETHINDRONEACTIVE INGREDIENTT18F433X4SDEBLITANE (NORETHINDRONE) KIT [NORTHSTAR RX LLC]1
NORETHINDRONEACTIVE MOIETYT18F433X4SDEBLITANE (NORETHINDRONE) KIT [NORTHSTAR RX LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDEBLITANE (NORETHINDRONE) KIT [NORTHSTAR RX LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDEBLITANE (NORETHINDRONE) KIT [NORTHSTAR RX LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADEBLITANE (NORETHINDRONE) KIT [NORTHSTAR RX LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDEBLITANE (NORETHINDRONE) KIT [NORTHSTAR RX LLC]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62DEBLITANE (NORETHINDRONE) KIT [NORTHSTAR RX LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DEBLITANE (NORETHINDRONE) KIT [NORTHSTAR RX LLC]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PDEBLITANE (NORETHINDRONE) KIT [NORTHSTAR RX LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DEBLITANE (NORETHINDRONE) KIT [NORTHSTAR RX LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDEBLITANE (NORETHINDRONE) KIT [NORTHSTAR RX LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDEBLITANE (NORETHINDRONE) KIT [NORTHSTAR RX LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDEBLITANE (NORETHINDRONE) KIT [NORTHSTAR RX LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-440DEBLITANE (NORETHINDRONE) KIT [NORTHSTAR RX LLC]5Current NDC, Legacy NDC, 8 package rows20240712_e75367ff-78af-4bd2-a99d-d291cb1d21eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1539953{28 (norethindrone 0.35 MG Oral Tablet) } Pack [Deblitane 28 Day]BPCKe75367ff-78af-4bd2-a99d-d291cb1d21eb6
748961{28 (norethindrone 0.35 MG Oral Tablet) } PackGPCKe75367ff-78af-4bd2-a99d-d291cb1d21eb6
1539953Deblitane 28 Day PackPSNe75367ff-78af-4bd2-a99d-d291cb1d21eb6
748961Noreth 0.35 MG (28) Oral Tablet 28 Day PackPSNe75367ff-78af-4bd2-a99d-d291cb1d21eb6
198042norethindrone 0.35 MG Oral TabletPSNe75367ff-78af-4bd2-a99d-d291cb1d21eb6
198042norethindrone 0.35 MG Oral TabletSCDe75367ff-78af-4bd2-a99d-d291cb1d21eb6
1539953Deblitane 28 Day PackSYe75367ff-78af-4bd2-a99d-d291cb1d21eb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-440-01167140440011 BLISTER PACK in 1 PACKET (16714-440-01) / 1 KIT in 1 BLISTER PACK1 blister pack2013-09-130000-00-00NoNoCurrent
16714-440-02167140440021 BLISTER PACK in 1 CARTON (16714-440-02) / 1 KIT in 1 BLISTER PACK1 blister pack2020-01-010000-00-00NoNoCurrent
16714-440-03167140440033 BLISTER PACK in 1 CARTON (16714-440-03) / 1 KIT in 1 BLISTER PACK3 blister pack2020-01-010000-00-00NoNoCurrent
16714-440-04167140440046 BLISTER PACK in 1 CARTON (16714-440-04) / 1 KIT in 1 BLISTER PACK6 blister pack2013-09-130000-00-00NoNoCurrent