FDA.reportPublic FDA data

Medroxyprogesterone Acetate

Product NDC
55289-160
11-digit product format
552890160
Labeler code
55289
Product ID
55289-160_2abe084b-747a-e923-e063-6394a90ac941
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Medroxyprogesterone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
55289-160-05Medroxyprogesterone Acetate5 in 1 BOTTLE, PLASTICTABLET524
55289-160-10Medroxyprogesterone Acetate10 in 1 BOTTLE, PLASTICTABLET1024
55289-160-30Medroxyprogesterone Acetate30 in 1 BOTTLE, PLASTICTABLET3024
55289-160-50Medroxyprogesterone Acetate50 in 1 BOTTLE, PLASTICTABLET5024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-160-05EA - Each55289-1601d11668e-c08c-439e-874a-2596ac192a8012012-07-24
55289-160-07EA - Each55289-160fedc871d-ed7e-4a64-9eb5-94bfa18fddec12012-07-24
55289-160-10EA - Each55289-1601c43c8fb-0f0b-4412-be2f-6f60b8b9a4cf12012-07-24
55289-160-13EA - Each55289-16063eeabfc-9904-4da8-8c39-f1ea9879cd6812012-07-24
55289-160-30EA - Each55289-160d0614a7b-fd63-4745-b917-c4ea5318175312012-07-24
55289-160-40EA - Each55289-1603e1a766a-6c92-4676-8e18-ccde243da65f12012-07-24
55289-160-42EA - Each55289-160f7676bb2-9775-4594-b435-347205b67c8412012-07-24
55289-160-50EA - Each55289-160679eb90b-6402-4147-8cdd-0155938319b912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]2
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]2
METHYLCELLULOSE (15 CPS)INACTIVE INGREDIENTNPU9M2E6L8MEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-160MEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]24Current NDC, Legacy NDC, 4 package rows20250104_437edd12-2c08-4df4-8cf7-64c47e4779ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSN437edd12-2c08-4df4-8cf7-64c47e4779ac24
1000114medroxyprogesterone acetate 10 MG Oral TabletSCD437edd12-2c08-4df4-8cf7-64c47e4779ac24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-160-05552890160055 TABLET in 1 BOTTLE, PLASTIC (55289-160-05) 5 tablet2011-01-180000-00-00NoNoCurrent
55289-160-07552890160077 TABLET in 1 BOTTLE, PLASTIC (55289-160-07) 7 tablet2011-01-180000-00-00NoNoCurrent
55289-160-105528901601010 TABLET in 1 BOTTLE, PLASTIC (55289-160-10) 10 tablet2011-01-180000-00-00NoNoCurrent
55289-160-135528901601313 TABLET in 1 BOTTLE, PLASTIC (55289-160-13) 13 tablet2011-01-180000-00-00NoNoCurrent
55289-160-305528901603030 TABLET in 1 BOTTLE, PLASTIC (55289-160-30) 30 tablet2011-01-180000-00-00NoNoCurrent
55289-160-405528901604040 TABLET in 1 BOTTLE, PLASTIC (55289-160-40) 40 tablet2011-01-180000-00-00NoNoCurrent
55289-160-425528901604242 TABLET in 1 BOTTLE, PLASTIC (55289-160-42) 42 tablet2011-01-180000-00-00NoNoCurrent
55289-160-505528901605050 TABLET in 1 BOTTLE, PLASTIC (55289-160-50) 50 tablet2011-01-180000-00-00NoNoCurrent