FDA.reportPublic FDA data

Medroxyprogesterone Acetate

Product NDC
63187-382
11-digit product format
631870382
Labeler code
63187
Product ID
63187-382_867e0dca-0472-415c-97f5-340123e86116
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Medroxyprogesterone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040159
Marketing category
ANDA
Marketing start
1996-12-04
Substance
MEDROXYPROGESTERONE ACETATE
Active strength
10 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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEDROXYPROGESTERONE ACETATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC2QI4IOI2G
Rxcui1000114

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
63187-382-10Medroxyprogesterone Acetate10 in 1 BOTTLETABLET105
63187-382-20Medroxyprogesterone Acetate20 in 1 BOTTLETABLET205
63187-382-30Medroxyprogesterone Acetate30 in 1 BOTTLETABLET305
63187-382-40Medroxyprogesterone Acetate40 in 1 BOTTLETABLET405
63187-382-60Medroxyprogesterone Acetate60 in 1 BOTTLETABLET605
63187-382-90Medroxyprogesterone Acetate90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-382-10EA - Each63187-3822c42710b-5fd8-4cb1-9c40-28cd3e4e3fe812019-04-11
63187-382-20EA - Each63187-38238662511-5379-4b7d-abcd-e8fd522d6d4212016-11-08
63187-382-30EA - Each63187-382a8699e1f-e3f7-42c3-ba6b-017dce8dad6612018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-382MEDROXYPROGESTERONE ACETATE TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 6 package rows20230225_0df6fd1e-7d9c-4a38-848c-1e562e211c91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSN0df6fd1e-7d9c-4a38-848c-1e562e211c915
1000114medroxyprogesterone acetate 10 MG Oral TabletSCD0df6fd1e-7d9c-4a38-848c-1e562e211c915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-382-106318703821010 TABLET in 1 BOTTLE (63187-382-10) 10 tablet2019-02-010000-00-00NoNoCurrent
63187-382-206318703822020 TABLET in 1 BOTTLE (63187-382-20) 20 tablet2016-09-010000-00-00NoNoCurrent
63187-382-306318703823030 TABLET in 1 BOTTLE (63187-382-30) 30 tablet2016-09-010000-00-00NoNoCurrent
63187-382-406318703824040 TABLET in 1 BOTTLE (63187-382-40) 40 tablet2016-09-010000-00-00NoNoCurrent
63187-382-606318703826060 TABLET in 1 BOTTLE (63187-382-60) 60 tablet2016-09-010000-00-00NoNoCurrent
63187-382-906318703829090 TABLET in 1 BOTTLE (63187-382-90) 90 tablet2016-09-010000-00-00NoNoCurrent