Progesterone

Product NDC
42291-785
11-digit product format
422910785
Labeler code
42291
Product ID
42291-785_51b5c47b-1c07-0bfb-e063-6294a90aab09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Progesterone
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA205229
Marketing category
ANDA
Marketing start
2024-04-16
Substance
PROGESTERONE
Active strength
200 mg/1
Pharmacologic classes
Progesterone [CS], Progesterone [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Progesterone
Listing expiration
2027-12-31

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
42291-785-01Progesterone100 in 1 BOTTLECAPSULE1003
42291-785-30Progesterone30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-785-01EA - Each42291-785690007af-ba0c-49b6-a206-4e30c5546ded12024-05-16
42291-785-30EA - Each42291-785627a1b6b-d8d5-4aa3-ab55-50dce8edc54e12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-785PROGESTERONE CAPSULE [AVKARE]2Current NDC, 2 package rows20240615_1637ac18-3a37-f3d5-e063-6394a90af157.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260243progesterone 100 MG Oral CapsulePSN1637ac18-3a37-f3d5-e063-6394a90af1573
312641progesterone 200 MG Oral CapsulePSN1637ac18-3a37-f3d5-e063-6394a90af1573
260243progesterone 100 MG Oral CapsuleSCD1637ac18-3a37-f3d5-e063-6394a90af1573
312641progesterone 200 MG Oral CapsuleSCD1637ac18-3a37-f3d5-e063-6394a90af1573

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42291-785-0142291078501100 CAPSULE in 1 BOTTLE (42291-785-01) 100 capsule2024-04-16NoNoHistorical
42291-785-304229107853030 in 1 BOTTLEHistorical