FDA.reportPublic FDA data

Medroxyprogesterone Acetate

Product NDC
60687-105
11-digit product format
606870105
Labeler code
60687
Product ID
60687-105_437e974f-f71e-5254-e063-6394a90a2ce2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Medroxyprogesterone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA040159
Marketing category
ANDA
Marketing start
2016-04-05
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
60687-105-11Medroxyprogesterone Acetate1 in 1 BLISTER PACKTABLET16
60687-105-21Medroxyprogesterone Acetate30 in 1 BOX, UNIT-DOSETABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-105-11EA - Each60687-105be34f032-b2f4-40b1-9f82-5c3053843c1812016-05-16
60687-105-21EA - Each60687-1056e3abfcf-9406-4851-8f8c-51ec97721e1f12016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]1
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEDROXYPROGESTERONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEDROXYPROGESTERONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDROXYPROGESTERONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]1
METHYLCELLULOSE (15 MPA.S)INACTIVE INGREDIENTNPU9M2E6L8MEDROXYPROGESTERONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEDROXYPROGESTERONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROXYPROGESTERONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-105MEDROXYPROGESTERONE ACETATE TABLET [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 2 package rows20240504_cbf142f9-9af3-4d79-9343-0ab42d6dbe9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSNcbf142f9-9af3-4d79-9343-0ab42d6dbe9f6
1000114medroxyprogesterone acetate 10 MG Oral TabletSCDcbf142f9-9af3-4d79-9343-0ab42d6dbe9f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-105-11606870105111 in 1 BLISTER PACKHistorical
60687-105-216068701052130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-105-21) / 1 TABLET in 1 BLISTER PACK (60687-105-11) 30 blister pack2016-04-190000-00-00NoNoCurrent