FDA.reportPublic FDA data

Medroxyprogesterone Acetate

Product NDC
33261-534
11-digit product format
332610534
Labeler code
33261
Product ID
33261-534_625f2552-b7bf-4ee3-a58e-9e22578f2280
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Medroxyprogesterone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA040159
Marketing category
ANDA
Marketing start
1996-12-04
Marketing end
0000-00-00
Substance
MEDROXYPROGESTERONE ACETATE
Active strength
10 mg/1
Pharmacologic classes
Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-534-052020-01-31C16284748780-19d75b9cf-f1c1-f424-e053-dadaa90a57ceMedroxyprogesterone Acetate Tablets USP
33261-534-102020-01-31C16284748780-19d75b9cf-f1c1-f424-e053-dadaa90a57ceMedroxyprogesterone Acetate Tablets USP
33261-534-142020-01-31C16284748780-19d75b9cf-f1c1-f424-e053-dadaa90a57ceMedroxyprogesterone Acetate Tablets USP
33261-534-302020-01-31C16284748780-19d75b9cf-f1c1-f424-e053-dadaa90a57ceMedroxyprogesterone Acetate Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-534-05Medroxyprogesterone Acetate5 in 1 BOTTLE, PLASTICTABLET51
33261-534-10Medroxyprogesterone Acetate10 in 1 BOTTLE, PLASTICTABLET101
33261-534-14Medroxyprogesterone Acetate14 in 1 BOTTLE, PLASTICTABLET141
33261-534-30Medroxyprogesterone Acetate30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-534-05EA - Each33261-534040e5a59-7491-4cfe-9386-29e0f464711812016-09-02
33261-534-10EA - Each33261-534bb92e699-f17c-4c91-93f6-85520f3fc2c212016-09-02
33261-534-14EA - Each33261-5344d58962a-b76c-41e9-a698-1e2b11c88d1112016-09-02
33261-534-30EA - Each33261-534221d4a09-b6c7-4de8-a639-f48b12e8519c12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
33261-534MEDROXYPROGESTERONE ACETATE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 4 package rows20140128_fda3368b-4ce3-4972-885d-066858831ee0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionStatus
33261-534-05332610534055 in 1 BOTTLE, PLASTICHistorical
33261-534-103326105341010 in 1 BOTTLE, PLASTICHistorical
33261-534-143326105341414 in 1 BOTTLE, PLASTICHistorical
33261-534-303326105343030 in 1 BOTTLE, PLASTICHistorical