Medroxyprogesterone Acetate

Product NDC
68788-8112
11-digit product format
687888112
Labeler code
68788
Product ID
68788-8112_eb5a5d6e-84fd-445b-ae1f-e339a2054632
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Medroxyprogesterone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA040159
Marketing category
ANDA
Marketing start
2021-12-06
Substance
MEDROXYPROGESTERONE ACETATE
Active strength
5 mg/1
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEDROXYPROGESTERONE ACETATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC2QI4IOI2G

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b8fdf1ba-dff9-e1f2-2551-c9b63aaa8dceProduct name620240606
882e78d5-69f7-4a43-812f-1c1628241bbcProduct name120150910
034a0bf8-c98c-0b66-1310-f87bb3a2f8a2Product name120140508
51a98800-9a04-9e42-2219-e588f17f9e48Product name120140508
f363ed61-d8ad-8f59-ee92-52a12578e008Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8112-3Medroxyprogesterone Acetate30 in 1 BOTTLETABLET305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8112-3EA - Each68788-81125cc150c9-d705-41ea-8af9-91286cb73c7412022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8112MEDROXYPROGESTERONE ACETATE TABLET [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 1 package rows20240704_a9e05272-aa4e-4df8-b08b-481abca3e8fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000141medroxyPROGESTERone acetate 5 MG Oral TabletPSNa9e05272-aa4e-4df8-b08b-481abca3e8fd5
1000141medroxyprogesterone acetate 5 MG Oral TabletSCDa9e05272-aa4e-4df8-b08b-481abca3e8fd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8112-36878881120330 TABLET in 1 BOTTLE (68788-8112-3) 30 tablet2021-12-060000-00-00NoNoCurrent