Norethindrone Acetate

Product NDC
0555-0211
11-digit product format
005550211
Labeler code
0555
Product ID
0555-0211_953441f0-0a24-40ba-a433-1de55da3ebaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norethindrone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA075951
Marketing category
ANDA
Marketing start
2001-06-29
Substance
NORETHINDRONE ACETATE
Active strength
5 mg/1
Pharmacologic classes
Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NORETHINDRONE ACETATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9S44LIC7OJ
Rxcui1000405

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d39a542a-f5b0-4c2d-a820-0f5d39e6621fProduct name120250307
859c4b0b-8cba-4f41-9afe-cc181a01fb62Product name220240215
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
0555-0211-10Norethindrone Acetate50 in 1 BOTTLETABLET509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-0211-10EA - Each0555-021128513b26-4306-439a-90d6-ff69a41b827312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NORETHINDRONE ACETATEACTIVE INGREDIENT9S44LIC7OJNORETHINDRONE ACETATE TABLET [BARR LABORATORIES INC.]3
NORETHINDRONEACTIVE MOIETYT18F433X4SNORETHINDRONE ACETATE TABLET [BARR LABORATORIES INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKNORETHINDRONE ACETATE TABLET [BARR LABORATORIES INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNORETHINDRONE ACETATE TABLET [BARR LABORATORIES INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NORETHINDRONE ACETATE TABLET [BARR LABORATORIES INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-0211NORETHINDRONE ACETATE TABLET [TEVA PHARMACEUTICALS USA, INC.]9Current NDC, Legacy NDC, 1 package rows20241212_f73f9807-4af6-4faa-ba9a-656a47a4c5e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000405norethindrone acetate 5 MG Oral TabletPSNf73f9807-4af6-4faa-ba9a-656a47a4c5e09
1000405norethindrone acetate 5 MG Oral TabletSCDf73f9807-4af6-4faa-ba9a-656a47a4c5e09
1000405norethindrone acetate 5 MG Oral TabletPSN2bb29135-6e9b-a9e2-e063-6394a90ae9e41
1000405norethindrone acetate 5 MG Oral TabletSCD2bb29135-6e9b-a9e2-e063-6394a90ae9e41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-0211-100055502111050 TABLET in 1 BOTTLE (0555-0211-10) 50 tablet2001-06-290000-00-00NoNoCurrent