FDA.reportPublic FDA data

medroxyprogesterone acetate

Product NDC
50090-5619
11-digit product format
500905619
Labeler code
50090
Product ID
50090-5619_30ad1e54-028e-498e-bb96-aa5f31235854
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
medroxyprogesterone acetate
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
A-S Medication Solutions
Application
NDA020246
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-07-06
Substance
MEDROXYPROGESTERONE ACETATE
Active strength
150 mg/mL
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 ACETATE150 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC2QI4IOI2G
Rxcui1000126

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b8fdf1ba-dff9-e1f2-2551-c9b63aaa8dceProduct name620240606
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
882e78d5-69f7-4a43-812f-1c1628241bbcProduct name120150910
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
034a0bf8-c98c-0b66-1310-f87bb3a2f8a2Product name120140508
51a98800-9a04-9e42-2219-e588f17f9e48Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
f363ed61-d8ad-8f59-ee92-52a12578e008Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5619-02023-02-07C16284748780-1f386c649-c209-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MEDROXYPROGESTERONE ACETATE (MPA) Injectable Suspension, USP safely and effectively. See full prescribing information for MPA INJECTABLE SUSPENSION, USP. MEDROXYPROGESTERONE ACETATE (MPA) Injectable Suspension, USP, for intramuscular use Initial U.S. Approval: 1959
50090-5619-02023-01-30C16284748780-1f386c649-c209-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MEDROXYPROGESTERONE ACETATE (MPA) Injectable Suspension, USP safely and effectively. See full prescribing information for MPA INJECTABLE SUSPENSION, USP. MEDROXYPROGESTERONE ACETATE (MPA) Injectable Suspension, USP, for intramuscular use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5619-0medroxyprogesterone acetate1 mL in 1 VIALINJECTION, SUSPENSION16
50090-5619-0medroxyprogesterone acetate1 in 1 CARTONINJECTION, SUSPENSION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5619MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 2 package rows20230208_5e817926-ba15-4d16-9463-88f6ff3bd3ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000126medroxyPROGESTERone acetate 150 MG in 1 ML InjectionPSN5e817926-ba15-4d16-9463-88f6ff3bd3ac6
10001261 ML medroxyprogesterone acetate 150 MG/ML InjectionSCD5e817926-ba15-4d16-9463-88f6ff3bd3ac6
1000126medroxyprogesterone acetate 150 MG per 1 ML InjectionSY5e817926-ba15-4d16-9463-88f6ff3bd3ac6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5619-0500905619001 VIAL in 1 CARTON (50090-5619-0) / 1 mL in 1 VIAL1 vial2021-08-250000-00-00NoNoCurrent