Norethindrone

Product NDC
0378-7272
11-digit product format
003787272
Labeler code
0378
Product ID
0378-7272_86deb6b8-705c-4086-bded-e8eff7306208
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norethindrone
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA200980
Marketing category
ANDA
Marketing start
2013-06-24
Marketing end
2026-05-31
Substance
NORETHINDRONE
Active strength
.35 mg/1
Pharmacologic classes
Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag
No
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d39a542a-f5b0-4c2d-a820-0f5d39e6621fProduct name120250307
859c4b0b-8cba-4f41-9afe-cc181a01fb62Product name220240215
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
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
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
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-7272-53Norethindrone3 in 1 CARTONTABLET313
0378-7272-85Norethindrone1 in 1 POUCHTABLET113
0378-7272-85Norethindrone28 in 1 BLISTER PACKTABLET2813

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7272-53EA - Each0378-72728655e7d1-6c69-41de-9ed9-68c596285c2f12013-07-02
0378-7272-85EA - Each0378-7272639a849f-480c-4531-96db-aa7ee4b221cf12018-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NORETHINDRONEACTIVE INGREDIENTT18F433X4SNORETHINDRONE TABLET [MYLAN PHARMACEUTICALS INC.]4
NORETHINDRONEACTIVE MOIETYT18F433X4SNORETHINDRONE TABLET [MYLAN PHARMACEUTICALS INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKNORETHINDRONE TABLET [MYLAN PHARMACEUTICALS INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNORETHINDRONE TABLET [MYLAN PHARMACEUTICALS INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNORETHINDRONE TABLET [MYLAN PHARMACEUTICALS INC.]4
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BNORETHINDRONE TABLET [MYLAN PHARMACEUTICALS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NORETHINDRONE TABLET [MYLAN PHARMACEUTICALS INC.]4
POVIDONEINACTIVE INGREDIENTFZ989GH94ENORETHINDRONE TABLET [MYLAN PHARMACEUTICALS INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2NORETHINDRONE TABLET [MYLAN PHARMACEUTICALS INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNORETHINDRONE TABLET [MYLAN PHARMACEUTICALS INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UNORETHINDRONE TABLET [MYLAN PHARMACEUTICALS INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7272NORETHINDRONE TABLET [MYLAN PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 3 package rows20250221_8d81169e-63ef-4454-b203-561db1e4bf33.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-7272-53003787272533 POUCH in 1 CARTON (0378-7272-53) / 1 BLISTER PACK in 1 POUCH (0378-7272-85) / 28 TABLET in 1 BLISTER PACK3 pouch2013-06-242026-05-31NoNoCurrent
0378-7272-85003787272851 in 1 POUCHHistorical