FDA.reportPublic FDA data

PROGESTERONE

Product NDC
76420-580
11-digit product format
764200580
Labeler code
76420
Product ID
76420-580_3485f152-22bd-e5bd-e063-6394a90afa5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROGESTERONE
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA200900
Marketing category
ANDA
Marketing start
2018-11-28
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
76420-580-10PROGESTERONE100 in 1 BOTTLECAPSULE1002
76420-580-30PROGESTERONE30 in 1 BOTTLECAPSULE302
76420-580-60PROGESTERONE60 in 1 BOTTLECAPSULE602
76420-580-90PROGESTERONE90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-580PROGESTERONE CAPSULE [ASCLEMED USA, INC.]2Current NDC, 4 package rows20250508_342a096d-df6f-47de-bdd1-ec259638e476.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260243progesterone 100 MG Oral CapsulePSN342a096d-df6f-47de-bdd1-ec259638e4762
312641progesterone 200 MG Oral CapsulePSN342a096d-df6f-47de-bdd1-ec259638e4762
260243progesterone 100 MG Oral CapsuleSCD342a096d-df6f-47de-bdd1-ec259638e4762
312641progesterone 200 MG Oral CapsuleSCD342a096d-df6f-47de-bdd1-ec259638e4762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-580-1076420058010100 CAPSULE in 1 BOTTLE (76420-580-10) 100 capsule2023-08-18NoNoHistorical
76420-580-307642005803030 CAPSULE in 1 BOTTLE (76420-580-30) 30 capsule2023-08-18NoNoHistorical
76420-580-607642005806060 CAPSULE in 1 BOTTLE (76420-580-60) 60 capsule2023-08-18NoNoHistorical
76420-580-907642005809090 CAPSULE in 1 BOTTLE (76420-580-90) 90 capsule2023-08-18NoNoHistorical