FDA.reportPublic FDA data

Medroxyprogesterone Acetate

Product NDC
63629-2612
11-digit product format
636292612
Labeler code
63629
Product ID
63629-2612_73260b93-2e18-45ed-88f8-dbb0b33e91e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Medroxyprogesterone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-2612-12020-10-16C16284748780-19d75b9d0-f466-f424-e053-dadaa90a57ceMedroxyPROGESTERone Acetate Tablets, USP
63629-2612-22020-10-16C16284748780-19d75b9d0-f466-f424-e053-dadaa90a57ceMedroxyPROGESTERone Acetate Tablets, USP
63629-2612-32020-10-16C16284748780-19d75b9d0-f466-f424-e053-dadaa90a57ceMedroxyPROGESTERone Acetate Tablets, USP
63629-2612-42020-10-16C16284748780-19d75b9d0-f466-f424-e053-dadaa90a57ceMedroxyPROGESTERone Acetate Tablets, USP
63629-2612-52020-10-16C16284748780-19d75b9d0-f466-f424-e053-dadaa90a57ceMedroxyPROGESTERone Acetate Tablets, USP
63629-2612-62020-10-16C16284748780-19d75b9d0-f466-f424-e053-dadaa90a57ceMedroxyPROGESTERone Acetate Tablets, USP
63629-2612-72020-10-16C16284748780-19d75b9d0-f466-f424-e053-dadaa90a57ceMedroxyPROGESTERone Acetate Tablets, USP
63629-2612-12020-01-31C16284748780-19d75b9d0-f466-f424-e053-dadaa90a57ceMedroxyPROGESTERone Acetate Tablets, USP
63629-2612-22020-01-31C16284748780-19d75b9d0-f466-f424-e053-dadaa90a57ceMedroxyPROGESTERone Acetate Tablets, USP
63629-2612-32020-01-31C16284748780-19d75b9d0-f466-f424-e053-dadaa90a57ceMedroxyPROGESTERone Acetate Tablets, USP
63629-2612-42020-01-31C16284748780-19d75b9d0-f466-f424-e053-dadaa90a57ceMedroxyPROGESTERone Acetate Tablets, USP
63629-2612-52020-01-31C16284748780-19d75b9d0-f466-f424-e053-dadaa90a57ceMedroxyPROGESTERone Acetate Tablets, USP
63629-2612-62020-01-31C16284748780-19d75b9d0-f466-f424-e053-dadaa90a57ceMedroxyPROGESTERone Acetate Tablets, USP
63629-2612-72020-01-31C16284748780-19d75b9d0-f466-f424-e053-dadaa90a57ceMedroxyPROGESTERone Acetate Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2612-1Medroxyprogesterone Acetate10 in 1 BOTTLETABLET101012
63629-2612-2Medroxyprogesterone Acetate30 in 1 BOTTLETABLET301012
63629-2612-3Medroxyprogesterone Acetate5 in 1 BOTTLETABLET51012
63629-2612-4Medroxyprogesterone Acetate60 in 1 BOTTLETABLET601012
63629-2612-5Medroxyprogesterone Acetate90 in 1 BOTTLETABLET901012
63629-2612-6Medroxyprogesterone Acetate20 in 1 BOTTLETABLET201012
63629-2612-7Medroxyprogesterone Acetate100 in 1 BOTTLETABLET1001012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2612-1EA - Each63629-2612ee8a3f63-d2df-4aad-a99d-1aee0ba32fe012013-02-13
63629-2612-2EA - Each63629-2612b59ed734-06b8-45d4-a3a0-a7c5d653272712013-02-13
63629-2612-7EA - Each63629-26124e9c8966-1218-48ca-bfde-1f08be461d7412025-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1001
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1001
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1001
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1001
METHYLCELLULOSE (15 CPS)INACTIVE INGREDIENTNPU9M2E6L8MEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1001
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1001
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2612MEDROXYPROGESTERONE ACETATE TABLET [BRYANT RANCH PREPACK]1012Current NDC, Legacy NDC, 7 package rows20240724_bdb89690-ced2-48e1-bb1a-e5eccfeda8eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSNbdb89690-ced2-48e1-bb1a-e5eccfeda8eb1012
1000114medroxyprogesterone acetate 10 MG Oral TabletSCDbdb89690-ced2-48e1-bb1a-e5eccfeda8eb1012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2612-16362926120110 TABLET in 1 BOTTLE (63629-2612-1) 10 tablet2011-06-130000-00-00NoNoCurrent
63629-2612-26362926120230 TABLET in 1 BOTTLE (63629-2612-2) 30 tablet2007-08-170000-00-00NoNoCurrent
63629-2612-3636292612035 TABLET in 1 BOTTLE (63629-2612-3) 5 tablet2011-08-120000-00-00NoNoCurrent
63629-2612-46362926120460 TABLET in 1 BOTTLE (63629-2612-4) 60 tablet2016-06-140000-00-00NoNoCurrent
63629-2612-56362926120590 TABLET in 1 BOTTLE (63629-2612-5) 90 tablet2021-07-280000-00-00NoNoCurrent
63629-2612-66362926120620 TABLET in 1 BOTTLE (63629-2612-6) 20 tablet2024-07-080000-00-00NoNoCurrent
63629-2612-763629261207100 TABLET in 1 BOTTLE (63629-2612-7) 100 tablet2017-10-090000-00-00NoNoCurrent