Medroxyprogesterone Acetate

Product NDC
51655-520
11-digit product format
516550520
Labeler code
51655
Product ID
51655-520_494db8a4-abf9-6e3f-e063-6394a90a6d24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Medroxyprogesterone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA040159
Marketing category
ANDA
Marketing start
2023-12-27
Substance
MEDROXYPROGESTERONE ACETATE
Active strength
10 mg/1
Pharmacologic classes
Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Medroxyprogesterone Acetate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEDROXYPROGESTERONE ACETATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC2QI4IOI2G
Rxcui1000114

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b8fdf1ba-dff9-e1f2-2551-c9b63aaa8dceProduct name620240606
882e78d5-69f7-4a43-812f-1c1628241bbcProduct name120150910
034a0bf8-c98c-0b66-1310-f87bb3a2f8a2Product name120140508
51a98800-9a04-9e42-2219-e588f17f9e48Product name120140508
f363ed61-d8ad-8f59-ee92-52a12578e008Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-520-52Medroxyprogesterone Acetate30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-520MEDROXYPROGESTERONE ACETATE TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 1 package rows20240724_0de6142f-a78e-ae58-e063-6394a90adff0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSN0de6142f-a78e-ae58-e063-6394a90adff03
1000114medroxyprogesterone acetate 10 MG Oral TabletSCD0de6142f-a78e-ae58-e063-6394a90adff03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-520-525165505205230 TABLET in 1 BOTTLE, PLASTIC (51655-520-52) 30 tablet2023-12-27NoNoCurrent