Nora BE

Product NDC
0480-3475
11-digit product format
004803475
Labeler code
0480
Product ID
0480-3475_3f6f53f3-b61a-45d9-94ed-d2946a17212e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norethindrone
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals, Inc.
Application
NDA017060
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2023-12-01
Substance
NORETHINDRONE
Active strength
.35 mg/1
Pharmacologic classes
Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
T18F433X4SNORETHINDRONE68-22-4NORETHINDRONE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0480-3475-16004803475166 PACKAGE in 1 CARTON (0480-3475-16) / 28 TABLET in 1 PACKAGE6 package2023-12-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Nora-BE ® (Norethindrone 0.35 mg tablets USP)Teva Pharmaceuticals, Inc.2024-04-02HUMAN PRESCRIPTION DRUG LABEL3