MEDROXYPROGESTERONE ACETATE

Product NDC
62756-090
11-digit product format
627560090
Labeler code
62756
Product ID
62756-090_8e776908-1e91-4e7e-b3c1-e6fe8234ba75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MEDROXYPROGESTERONE ACETATE
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA210760
Marketing category
ANDA
Marketing start
2019-05-04
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
62756-090-40MEDROXYPROGESTERONE ACETATE1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION16
62756-090-40MEDROXYPROGESTERONE ACETATE1 in 1 CARTONINJECTION, SUSPENSION16
62756-090-45MEDROXYPROGESTERONE ACETATE1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION16
62756-090-45MEDROXYPROGESTERONE ACETATE25 in 1 CARTONINJECTION, SUSPENSION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-090-40ML - Milliliter62756-090d3583aab-9bf8-4a8b-9de8-c75ae2cd724d12019-12-10
62756-090-45ML - Milliliter62756-0904641a5ec-7b84-4df9-a1fb-4fed9d2f949312019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-090MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Current NDC, Legacy NDC, 4 package rows20210701_d1ea4098-6196-421f-b8e1-bcb31a061e04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000126medroxyPROGESTERone acetate 150 MG in 1 ML InjectionPSNd1ea4098-6196-421f-b8e1-bcb31a061e046
10001261 ML medroxyprogesterone acetate 150 MG/ML InjectionSCDd1ea4098-6196-421f-b8e1-bcb31a061e046
1000126medroxyprogesterone acetate 150 MG per 1 ML InjectionSYd1ea4098-6196-421f-b8e1-bcb31a061e046

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62756-090-40627560090401 VIAL, SINGLE-DOSE in 1 CARTON (62756-090-40) / 1 mL in 1 VIAL, SINGLE-DOSE2019-05-040000-00-00NoNoCurrent
62756-090-456275600904525 VIAL, SINGLE-DOSE in 1 CARTON (62756-090-45) / 1 mL in 1 VIAL, SINGLE-DOSE2019-05-040000-00-00NoNoCurrent