FDA.reportPublic FDA data

Medroxyprogesterone Acetate

Product NDC
70700-315
11-digit product format
707000315
Labeler code
70700
Product ID
70700-315_4f9af826-fda5-ed08-e063-6294a90a6b29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Medroxyprogesterone Acetate
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Xiromed LLC
Application
ANDA210227
Marketing category
ANDA
Marketing start
2024-03-12
Substance
MEDROXYPROGESTERONE ACETATE
Active strength
150 mg/mL
Pharmacologic classes
Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Medroxyprogesterone Acetate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEDROXYPROGESTERONE ACETATE150 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC2QI4IOI2G
Rxcui1000126

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b8fdf1ba-dff9-e1f2-2551-c9b63aaa8dceProduct name620240606
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
882e78d5-69f7-4a43-812f-1c1628241bbcProduct name120150910
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
034a0bf8-c98c-0b66-1310-f87bb3a2f8a2Product name120140508
51a98800-9a04-9e42-2219-e588f17f9e48Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
f363ed61-d8ad-8f59-ee92-52a12578e008Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70700-315-22Medroxyprogesterone Acetate1 mL in 1 CONTAINERINJECTION, SUSPENSION16
70700-315-25Medroxyprogesterone Acetate25 in 1 CARTONINJECTION, SUSPENSION256
70700-315-25Medroxyprogesterone Acetate1 mL in 1 VIALINJECTION, SUSPENSION16
70700-315-27Medroxyprogesterone Acetate1 in 1 CARTONINJECTION, SUSPENSION16
70700-315-27Medroxyprogesterone Acetate1 mL in 1 VIALINJECTION, SUSPENSION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-315-22ML - Milliliter70700-3152eee8a0f-f784-4e10-9882-ba4f038014f112025-08-11
70700-315-25ML - Milliliter70700-31523e690d4-a378-494c-86e3-063e87e7694512025-05-14
70700-315-27ML - Milliliter70700-315ad8e4eba-9297-4ec8-a4a7-741aa9679cef12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-315MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [XIROMED LLC]2Current NDC, 5 package rows20250123_24544a5d-0cf5-a099-b57c-6e0843a40532.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000126medroxyPROGESTERone acetate 150 MG in 1 ML InjectionPSN24544a5d-0cf5-a099-b57c-6e0843a405326
10001261 ML medroxyprogesterone acetate 150 MG/ML InjectionSCD24544a5d-0cf5-a099-b57c-6e0843a405326
1000126medroxyprogesterone acetate 150 MG per 1 ML InjectionSY24544a5d-0cf5-a099-b57c-6e0843a405326

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70700-315-22707000315221 mL in 1 CONTAINER (70700-315-22) 1 ml2024-03-12NoNoHistorical
70700-315-257070003152525 VIAL in 1 CARTON (70700-315-25) / 1 mL in 1 VIAL25 vial2024-03-12NoNoHistorical
70700-315-27707000315271 VIAL in 1 CARTON (70700-315-27) / 1 mL in 1 VIAL1 vial2024-03-12NoNoHistorical