FDA.reportPublic FDA data

medroxyprogesterone acetate

Product NDC
70518-4324
11-digit product format
705184324
Labeler code
70518
Product ID
70518-4324_402efbd6-18cd-3037-e063-6394a90a5c81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
medroxyprogesterone acetate
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
REMEDYREPACK INC.
Application
ANDA215397
Marketing category
ANDA
Marketing start
2025-04-01
Substance
MEDROXYPROGESTERONE ACETATE
Active strength
150 mg/mL
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
medroxyprogesterone acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEDROXYPROGESTERONE ACETATE150 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC2QI4IOI2G
Rxcui1000153

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4324-0medroxyprogesterone acetate1 in 1 CARTONINJECTION, SUSPENSION12
70518-4324-0medroxyprogesterone acetate1 mL in 1 SYRINGE, GLASSINJECTION, SUSPENSION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4324MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [REMEDYREPACK INC.]1Current NDC, 2 package rows20250406_a0a92717-c1cb-40eb-a95a-1c5dfd32cfc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000153medroxyPROGESTERone acetate 150 MG in 1 ML Prefilled SyringePSNa0a92717-c1cb-40eb-a95a-1c5dfd32cfc02
10001531 ML medroxyprogesterone acetate 150 MG/ML Prefilled SyringeSCDa0a92717-c1cb-40eb-a95a-1c5dfd32cfc02
1000153medroxyprogesterone acetate 150 MG per 1 ML Prefilled SyringeSYa0a92717-c1cb-40eb-a95a-1c5dfd32cfc02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4324-0705184324001 SYRINGE, GLASS in 1 CARTON (70518-4324-0) / 1 mL in 1 SYRINGE, GLASS2025-04-01NoNoHistorical