FDA.reportPublic FDA data

Progesterone

Product NDC
76420-059
11-digit product format
764200059
Labeler code
76420
Product ID
76420-059_ead2bd7f-b5e3-3c69-e053-2995a90adf37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Progesterone
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA207724
Marketing category
ANDA
Marketing start
2017-09-11
Substance
PROGESTERONE
Active strength
200 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
PROGESTERONE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4G7DS2Q64Y
Rxcui260243, 312641

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
76420-059-10Progesterone100 in 1 BOTTLECAPSULE1002
76420-059-30Progesterone30 in 1 BOTTLECAPSULE302
76420-059-90Progesterone90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-059PROGESTERONE CAPSULE [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 3 package rows20221013_19716042-8025-43a3-b26d-e0fd7d2587eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260243progesterone 100 MG Oral CapsulePSN19716042-8025-43a3-b26d-e0fd7d2587eb2
312641progesterone 200 MG Oral CapsulePSN19716042-8025-43a3-b26d-e0fd7d2587eb2
260243progesterone 100 MG Oral CapsuleSCD19716042-8025-43a3-b26d-e0fd7d2587eb2
312641progesterone 200 MG Oral CapsuleSCD19716042-8025-43a3-b26d-e0fd7d2587eb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-059-1076420005910100 CAPSULE in 1 BOTTLE (76420-059-10) 100 capsule2019-12-160000-00-00NoNoCurrent
76420-059-307642000593030 CAPSULE in 1 BOTTLE (76420-059-30) 30 capsule2019-12-160000-00-00NoNoCurrent
76420-059-907642000599090 CAPSULE in 1 BOTTLE (76420-059-90) 90 capsule2019-12-160000-00-00NoNoCurrent