Medroxyprogesterone Acetate

Product NDC
67046-1480
11-digit product format
670461480
Labeler code
67046
Product ID
67046-1480_2cf48b4a-6359-8dac-e063-6294a90a3a1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Medroxyprogesterone Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA040159
Marketing category
ANDA
Marketing start
2025-01-30
Substance
MEDROXYPROGESTERONE ACETATE
Active strength
2.5 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 ACETATE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC2QI4IOI2G
Rxcui1000135

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
67046-1480-3Medroxyprogesterone Acetate30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1480MEDROXYPROGESTERONE ACETATE TABLET [COUPLER LLC]1Current NDC, 1 package rows20250201_2cf48919-6de8-d3d0-e063-6394a90ac1bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000135medroxyPROGESTERone acetate 2.5 MG Oral TabletPSN2cf48919-6de8-d3d0-e063-6394a90ac1bc1
1000135medroxyprogesterone acetate 2.5 MG Oral TabletSCD2cf48919-6de8-d3d0-e063-6394a90ac1bc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1480-36704614800330 TABLET in 1 BLISTER PACK (67046-1480-3) 30 tablet2025-01-30NoNoHistorical