FDA.reportPublic FDA data

medroxyprogesterone acetate

Product NDC
70121-1467
11-digit product format
701211467
Labeler code
70121
Product ID
70121-1467_391fd062-e255-4396-aaff-027344c3a39d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
medroxyprogesterone acetate
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA215397
Marketing category
ANDA
Marketing start
2023-06-13
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, 1000153

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
70121-1467-2medroxyprogesterone acetate1 mL in 1 VIALINJECTION, SUSPENSION17
70121-1467-2medroxyprogesterone acetate1 in 1 CARTONINJECTION, SUSPENSION17
70121-1467-5medroxyprogesterone acetate1 mL in 1 VIALINJECTION, SUSPENSION17
70121-1467-5medroxyprogesterone acetate25 in 1 CARTONINJECTION, SUSPENSION257

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1467-2ML - Milliliter70121-146716097109-6c04-442c-9004-a9bd9b98427e12023-09-05
70121-1467-5ML - Milliliter70121-1467e70b481d-4a74-488e-b6a4-2ce3308aa1cb12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1467MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [AMNEAL PHARMACEUTICALS LLC]5Current NDC, 4 package rows20241117_6457d70a-2f25-4935-8511-726d988f7a03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000126medroxyPROGESTERone acetate 150 MG in 1 ML InjectionPSN6457d70a-2f25-4935-8511-726d988f7a037
1000153medroxyPROGESTERone acetate 150 MG in 1 ML Prefilled SyringePSN6457d70a-2f25-4935-8511-726d988f7a037
10001261 ML medroxyprogesterone acetate 150 MG/ML InjectionSCD6457d70a-2f25-4935-8511-726d988f7a037
10001531 ML medroxyprogesterone acetate 150 MG/ML Prefilled SyringeSCD6457d70a-2f25-4935-8511-726d988f7a037
1000126medroxyprogesterone acetate 150 MG per 1 ML InjectionSY6457d70a-2f25-4935-8511-726d988f7a037
1000153medroxyprogesterone acetate 150 MG per 1 ML Prefilled SyringeSY6457d70a-2f25-4935-8511-726d988f7a037

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70121-1467-2701211467021 VIAL in 1 CARTON (70121-1467-2) / 1 mL in 1 VIAL1 vial2023-06-13NoNoCurrent
70121-1467-57012114670525 VIAL in 1 CARTON (70121-1467-5) / 1 mL in 1 VIAL25 vial2023-06-13NoNoCurrent