PROGESTERONE

Product NDC
70518-4166
11-digit product format
705184166
Labeler code
70518
Product ID
70518-4166_3fb8473d-fe36-7387-e063-6294a90a350b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROGESTERONE
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA200900
Marketing category
ANDA
Marketing start
2024-08-22
Substance
PROGESTERONE
Active strength
100 mg/1
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
PROGESTERONE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4G7DS2Q64Y
Rxcui260243

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
70518-4166-0PROGESTERONE90 in 1 BOTTLE, PLASTICCAPSULE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4166PROGESTERONE CAPSULE [REMEDYREPACK INC.]1Current NDC, 1 package rows20241121_947ebb7c-492b-4b83-aa1c-81e282df6421.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260243progesterone 100 MG Oral CapsulePSN947ebb7c-492b-4b83-aa1c-81e282df64213
260243progesterone 100 MG Oral CapsuleSCD947ebb7c-492b-4b83-aa1c-81e282df64213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4166-07051841660090 CAPSULE in 1 BOTTLE, PLASTIC (70518-4166-0) 90 capsule2024-08-22NoNoCurrent