PROGESTERONE

Product NDC
70700-286
11-digit product format
707000286
Labeler code
70700
Product ID
70700-286_0f25eef8-d21f-138d-dd9c-550b42f355dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROGESTERONE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
XIROMED, LLC
Application
ANDA215634
Marketing category
ANDA
Marketing start
2022-03-29
Substance
PROGESTERONE
Active strength
50 mg/mL
Pharmacologic classes
Progesterone [CS], Progesterone [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PROGESTERONE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROGESTERONE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4G7DS2Q64Y
Rxcui312644

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b46148e2-ee15-98d5-12f0-f5ec8745f6fcProduct name320220927
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
d3229c1a-4e51-4e04-9b13-00d24fd35242Product name120200821
213f0591-95c1-b398-40b7-08b31f66b026Product name420190206
85b2d644-53b2-f2dc-4dbc-859116ce56c0Product name120140508
d048f0e3-3c40-8816-8c5c-0ca5cd189aacProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70700-286-22PROGESTERONE10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-286-22ML - Milliliter70700-286074a3d8f-523c-4198-b778-344d31b074d612022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-286PROGESTERONE INJECTION, SOLUTION [XIROMED, LLC]6Current NDC, Legacy NDC, 1 package rows20250309_dcfa4050-d142-b774-369f-8a421eb23c62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312644progesterone 50 MG/ML Injectable SolutionPSNdcfa4050-d142-b774-369f-8a421eb23c626
312644progesterone 50 MG/ML Injectable SolutionSCDdcfa4050-d142-b774-369f-8a421eb23c626

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70700-286-227070002862210 mL in 1 VIAL, MULTI-DOSE (70700-286-22) 10 ml2022-03-290000-00-00NoNoCurrent