FDA.reportPublic FDA data

PROGESTERONE

Product NDC
68071-3557
11-digit product format
680713557
Labeler code
68071
Product ID
68071-3557_1ce8680c-c73f-9d98-e063-6294a90a18bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROGESTERONE
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA200900
Marketing category
ANDA
Marketing start
2018-11-28
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
68071-3557-3PROGESTERONE30 in 1 BOTTLECAPSULE304
68071-3557-6PROGESTERONE60 in 1 BOTTLECAPSULE604
68071-3557-8PROGESTERONE180 in 1 BOTTLECAPSULE1804
68071-3557-9PROGESTERONE90 in 1 BOTTLECAPSULE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3557PROGESTERONE CAPSULE [NUCARE PHARMACEUTICALS,INC.]4Current NDC, 4 package rows20240711_0d976866-81b3-5db8-e063-6294a90a39f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260243progesterone 100 MG Oral CapsulePSN0d976866-81b3-5db8-e063-6294a90a39f94
260243progesterone 100 MG Oral CapsuleSCD0d976866-81b3-5db8-e063-6294a90a39f94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3557-36807135570330 CAPSULE in 1 BOTTLE (68071-3557-3) 30 capsule2023-12-28NoNoCurrent
68071-3557-66807135570660 CAPSULE in 1 BOTTLE (68071-3557-6) 60 capsule2023-12-28NoNoCurrent
68071-3557-868071355708180 CAPSULE in 1 BOTTLE (68071-3557-8) 180 capsule2023-12-28NoNoCurrent
68071-3557-96807135570990 CAPSULE in 1 BOTTLE (68071-3557-9) 90 capsule2023-12-28NoNoCurrent