MEDROXYPROGESTERONE ACETATE

Product NDC
62756-091
11-digit product format
627560091
Labeler code
62756
Product ID
62756-091_10fdc3f5-de88-4bbb-9f3f-c0a0630d0222
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MEDROXYPROGESTERONE ACETATE
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA210761
Marketing category
ANDA
Marketing start
2019-05-01
Substance
MEDROXYPROGESTERONE ACETATE
Active strength
150 mg/mL
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 ACETATE150 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC2QI4IOI2G
Rxcui1000153

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b8fdf1ba-dff9-e1f2-2551-c9b63aaa8dceProduct name620240606
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
882e78d5-69f7-4a43-812f-1c1628241bbcProduct name120150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
034a0bf8-c98c-0b66-1310-f87bb3a2f8a2Product name120140508
51a98800-9a04-9e42-2219-e588f17f9e48Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508
f363ed61-d8ad-8f59-ee92-52a12578e008Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62756-091-40MEDROXYPROGESTERONE ACETATE1 in 1 CARTONINJECTION, SUSPENSION17
62756-091-40MEDROXYPROGESTERONE ACETATE1 mL in 1 SYRINGEINJECTION, SUSPENSION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-091-40ML - Milliliter62756-091fa71aa50-c2de-4e77-a938-36357a5837f012021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-091MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [SUN PHARMACEUTICAL INDUSTRIES, INC.]7Current NDC, Legacy NDC, 2 package rows20221217_01e28bef-9758-40cf-a4ff-86ae9f4f5105.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000153medroxyPROGESTERone acetate 150 MG in 1 ML Prefilled SyringePSN01e28bef-9758-40cf-a4ff-86ae9f4f51057
10001531 ML medroxyprogesterone acetate 150 MG/ML Prefilled SyringeSCD01e28bef-9758-40cf-a4ff-86ae9f4f51057
1000153medroxyprogesterone acetate 150 MG per 1 ML Prefilled SyringeSY01e28bef-9758-40cf-a4ff-86ae9f4f51057

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-091-40627560091401 SYRINGE in 1 CARTON (62756-091-40) / 1 mL in 1 SYRINGE1 syringe2019-05-010000-00-00NoNoCurrent