Provera

Product NDC
0009-0051
11-digit product format
000090051
Labeler code
0009
Product ID
0009-0051_80c81ad8-3d42-4a21-ac4c-d331bc5e4956
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
medroxyprogesterone acetate
Dosage form
TABLET
Route
ORAL
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA011839
Marketing category
NDA
Marketing start
2020-07-20
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
Provera
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEDROXYPROGESTERONE ACETATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC2QI4IOI2G
Rxcui1000114, 1000124, 1000135, 1000139, 1000141, 1000145

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
0009-0051-01Provera100 in 1 BOTTLETABLET10026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-0051-01EA - Each0009-0051b64a3ec1-9d4c-45a8-8b77-51967899639b12020-08-06

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-0051PROVERA (MEDROXYPROGESTERONE ACETATE) TABLET [PHARMACIA & UPJOHN COMPANY LLC]26Current NDC, Legacy NDC, 1 package rows20240831_a586be28-96af-4fed-a13f-9b94fd4c7405.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSNa586be28-96af-4fed-a13f-9b94fd4c740526
1000135medroxyPROGESTERone acetate 2.5 MG Oral TabletPSNa586be28-96af-4fed-a13f-9b94fd4c740526
1000141medroxyPROGESTERone acetate 5 MG Oral TabletPSNa586be28-96af-4fed-a13f-9b94fd4c740526
1000124Provera 10 MG Oral TabletPSNa586be28-96af-4fed-a13f-9b94fd4c740526
1000139Provera 2.5 MG Oral TabletPSNa586be28-96af-4fed-a13f-9b94fd4c740526
1000145Provera 5 MG Oral TabletPSNa586be28-96af-4fed-a13f-9b94fd4c740526
1000124medroxyprogesterone acetate 10 MG Oral Tablet [Provera]SBDa586be28-96af-4fed-a13f-9b94fd4c740526
1000139medroxyprogesterone acetate 2.5 MG Oral Tablet [Provera]SBDa586be28-96af-4fed-a13f-9b94fd4c740526
1000145medroxyprogesterone acetate 5 MG Oral Tablet [Provera]SBDa586be28-96af-4fed-a13f-9b94fd4c740526
1000114medroxyprogesterone acetate 10 MG Oral TabletSCDa586be28-96af-4fed-a13f-9b94fd4c740526
1000135medroxyprogesterone acetate 2.5 MG Oral TabletSCDa586be28-96af-4fed-a13f-9b94fd4c740526
1000141medroxyprogesterone acetate 5 MG Oral TabletSCDa586be28-96af-4fed-a13f-9b94fd4c740526
1000124Provera 10 MG Oral TabletSYa586be28-96af-4fed-a13f-9b94fd4c740526
1000139Provera 2.5 MG Oral TabletSYa586be28-96af-4fed-a13f-9b94fd4c740526
1000145Provera 5 MG Oral TabletSYa586be28-96af-4fed-a13f-9b94fd4c740526

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-0051-0100009005101100 TABLET in 1 BOTTLE (0009-0051-01) 100 tablet2020-07-200000-00-00NoNoCurrent