FDA.reportPublic FDA data

Medroxyprogesterone Acetate

Product NDC
0555-0873
11-digit product format
005550873
Labeler code
0555
Product ID
0555-0873_b8f519a9-a8d0-4dd5-b138-564fb579c461
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Medroxyprogesterone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA040159
Marketing category
ANDA
Marketing start
1996-12-03
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEDROXYPROGESTERONE ACETATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC2QI4IOI2G
Rxcui1000114, 1000135, 1000141

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
0555-0873-02Medroxyprogesterone Acetate100 in 1 BOTTLETABLET10017
0555-0873-04Medroxyprogesterone Acetate500 in 1 BOTTLETABLET50017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-0873-02EA - Each0555-0873807ce876-a923-4e09-a4bb-e5f08ecb153412013-02-13
0555-0873-04EA - Each0555-08734969452d-e408-49e9-9d21-d7cc5f4e5ce412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE TABLET [BARR LABORATORIES INC.]8
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE TABLET [BARR LABORATORIES INC.]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEDROXYPROGESTERONE ACETATE TABLET [BARR LABORATORIES INC.]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEDROXYPROGESTERONE ACETATE TABLET [BARR LABORATORIES INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDROXYPROGESTERONE ACETATE TABLET [BARR LABORATORIES INC.]8
METHYLCELLULOSE (15 MPA.S)INACTIVE INGREDIENTNPU9M2E6L8MEDROXYPROGESTERONE ACETATE TABLET [BARR LABORATORIES INC.]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEDROXYPROGESTERONE ACETATE TABLET [BARR LABORATORIES INC.]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROXYPROGESTERONE ACETATE TABLET [BARR LABORATORIES INC.]8
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.]3
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.]3
METHYLCELLULOSE (15 MPA.S)INACTIVE INGREDIENTNPU9M2E6L8MEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROXYPROGESTERONE ACETATE TABLET [BLENHEIM PHARMACAL, INC.]3
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE TABLET [DISPENSING SOLUTIONS, INC.]2
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE TABLET [DISPENSING SOLUTIONS, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEDROXYPROGESTERONE ACETATE TABLET [DISPENSING SOLUTIONS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEDROXYPROGESTERONE ACETATE TABLET [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDROXYPROGESTERONE ACETATE TABLET [DISPENSING SOLUTIONS, INC.]2
METHYLCELLULOSE (15 CPS)INACTIVE INGREDIENTNPU9M2E6L8MEDROXYPROGESTERONE ACETATE TABLET [DISPENSING SOLUTIONS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEDROXYPROGESTERONE ACETATE TABLET [DISPENSING SOLUTIONS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROXYPROGESTERONE ACETATE TABLET [DISPENSING SOLUTIONS, INC.]2
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEDROXYPROGESTERONE ACETATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEDROXYPROGESTERONE ACETATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDROXYPROGESTERONE ACETATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
METHYLCELLULOSE (15 MPA.S)INACTIVE INGREDIENTNPU9M2E6L8MEDROXYPROGESTERONE ACETATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEDROXYPROGESTERONE ACETATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROXYPROGESTERONE ACETATE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-0873MEDROXYPROGESTERONE ACETATE TABLET [TEVA PHARMACEUTICALS USA, INC.]17Current NDC, Legacy NDC, 2 package rows20240620_9eb200b0-db96-4a51-87ea-04db862978c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000141medroxyPROGESTERone acetate 5 MG Oral TabletPSNa88b33ff-842b-4a5b-a27e-9c2b9e85a4d7103
1000141medroxyprogesterone acetate 5 MG Oral TabletSCDa88b33ff-842b-4a5b-a27e-9c2b9e85a4d7103
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSN9eb200b0-db96-4a51-87ea-04db862978c817
1000135medroxyPROGESTERone acetate 2.5 MG Oral TabletPSN9eb200b0-db96-4a51-87ea-04db862978c817
1000141medroxyPROGESTERone acetate 5 MG Oral TabletPSN9eb200b0-db96-4a51-87ea-04db862978c817
1000114medroxyprogesterone acetate 10 MG Oral TabletSCD9eb200b0-db96-4a51-87ea-04db862978c817
1000135medroxyprogesterone acetate 2.5 MG Oral TabletSCD9eb200b0-db96-4a51-87ea-04db862978c817
1000141medroxyprogesterone acetate 5 MG Oral TabletSCD9eb200b0-db96-4a51-87ea-04db862978c817
1000141medroxyPROGESTERone acetate 5 MG Oral TabletPSNbfdf335d-1cbb-4533-9fde-99a9c71f750413
1000141medroxyprogesterone acetate 5 MG Oral TabletSCDbfdf335d-1cbb-4533-9fde-99a9c71f750413
1000141medroxyPROGESTERone acetate 5 MG Oral TabletPSNa9e05272-aa4e-4df8-b08b-481abca3e8fd5
1000141medroxyprogesterone acetate 5 MG Oral TabletSCDa9e05272-aa4e-4df8-b08b-481abca3e8fd5
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSN826f674c-8ef2-400a-bf0b-877320a8cb5d3
1000141medroxyPROGESTERone acetate 5 MG Oral TabletPSN826f674c-8ef2-400a-bf0b-877320a8cb5d3
1000114medroxyprogesterone acetate 10 MG Oral TabletSCD826f674c-8ef2-400a-bf0b-877320a8cb5d3
1000141medroxyprogesterone acetate 5 MG Oral TabletSCD826f674c-8ef2-400a-bf0b-877320a8cb5d3
1000141medroxyPROGESTERone acetate 5 MG Oral TabletPSN210a9132-8837-4b8a-829c-abfac2d6e3dc2
1000141medroxyprogesterone acetate 5 MG Oral TabletSCD210a9132-8837-4b8a-829c-abfac2d6e3dc2
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSNfda3368b-4ce3-4972-885d-066858831ee01
1000135medroxyPROGESTERone acetate 2.5 MG Oral TabletPSNfda3368b-4ce3-4972-885d-066858831ee01
1000141medroxyPROGESTERone acetate 5 MG Oral TabletPSNfda3368b-4ce3-4972-885d-066858831ee01
1000114medroxyprogesterone acetate 10 MG Oral TabletSCDfda3368b-4ce3-4972-885d-066858831ee01
1000135medroxyprogesterone acetate 2.5 MG Oral TabletSCDfda3368b-4ce3-4972-885d-066858831ee01
1000141medroxyprogesterone acetate 5 MG Oral TabletSCDfda3368b-4ce3-4972-885d-066858831ee01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-0873-0200555087302100 TABLET in 1 BOTTLE (0555-0873-02) 100 tablet1996-12-040000-00-00NoNoCurrent
0555-0873-0400555087304500 TABLET in 1 BOTTLE (0555-0873-04) 500 tablet1996-12-040000-00-00NoNoCurrent