FDA.reportPublic FDA data

Medroxyprogesterone Acetate

Product NDC
60219-1467
11-digit product format
602191467
Labeler code
60219
Product ID
60219-1467_b18868d1-e830-4990-a0f2-66210a783d39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Medroxyprogesterone Acetate
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA210227
Marketing category
ANDA
Marketing start
2025-06-10
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60219-1467-1Medroxyprogesterone Acetate1 in 1 CARTONINJECTION, SUSPENSION13
60219-1467-1Medroxyprogesterone Acetate1 mL in 1 VIALINJECTION, SUSPENSION13
60219-1467-2Medroxyprogesterone Acetate1 mL in 1 VIALINJECTION, SUSPENSION13
60219-1467-2Medroxyprogesterone Acetate25 in 1 CARTONINJECTION, SUSPENSION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-1467-1ML - Milliliter60219-1467b9105793-36ae-4d6c-a0b4-482eb9b384ec12025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000126medroxyPROGESTERone acetate 150 MG in 1 ML InjectionPSNa80560e1-96dd-4380-b3e1-d52719ccdd4b3
10001261 ML medroxyprogesterone acetate 150 MG/ML InjectionSCDa80560e1-96dd-4380-b3e1-d52719ccdd4b3
1000126medroxyprogesterone acetate 150 MG per 1 ML InjectionSYa80560e1-96dd-4380-b3e1-d52719ccdd4b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60219-1467-1602191467011 VIAL in 1 CARTON (60219-1467-1) / 1 mL in 1 VIAL1 vial2025-06-10NoNoHistorical
60219-1467-26021914670225 VIAL in 1 CARTON (60219-1467-2) / 1 mL in 1 VIAL25 vial2025-06-10NoNoHistorical