FDA.reportPublic FDA data

PROGESTERONE

Product NDC
71335-2242
11-digit product format
713352242
Labeler code
71335
Product ID
71335-2242_c9c8915b-47cc-4b82-b222-d664d5f3e739
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROGESTERONE
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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
Rxcui312641

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
71335-2242-0PROGESTERONE120 in 1 BOTTLECAPSULE120102
71335-2242-1PROGESTERONE30 in 1 BOTTLECAPSULE30102
71335-2242-2PROGESTERONE28 in 1 BOTTLECAPSULE28102
71335-2242-3PROGESTERONE18 in 1 BOTTLECAPSULE18102
71335-2242-4PROGESTERONE90 in 1 BOTTLECAPSULE90102
71335-2242-5PROGESTERONE100 in 1 BOTTLECAPSULE100102
71335-2242-6PROGESTERONE6 in 1 BOTTLECAPSULE6102
71335-2242-7PROGESTERONE60 in 1 BOTTLECAPSULE60102
71335-2242-8PROGESTERONE180 in 1 BOTTLECAPSULE180102
71335-2242-9PROGESTERONE10 in 1 BOTTLECAPSULE10102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2242-1EA - Each71335-22427e4b7b2e-9f0f-4e95-a1ff-423e48870bbb12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2242PROGESTERONE CAPSULE [BRYANT RANCH PREPACK]101Current NDC, 10 package rows20250515_46d97ca6-970f-478f-81ff-1b9a9f6cb2f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312641progesterone 200 MG Oral CapsulePSN46d97ca6-970f-478f-81ff-1b9a9f6cb2f7102
312641progesterone 200 MG Oral CapsuleSCD46d97ca6-970f-478f-81ff-1b9a9f6cb2f7102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2242-071335224200120 CAPSULE in 1 BOTTLE (71335-2242-0) 120 capsule2023-09-22NoNoHistorical
71335-2242-17133522420130 CAPSULE in 1 BOTTLE (71335-2242-1) 30 capsule2023-09-22NoNoHistorical
71335-2242-27133522420228 CAPSULE in 1 BOTTLE (71335-2242-2) 28 capsule2023-09-22NoNoHistorical
71335-2242-37133522420318 CAPSULE in 1 BOTTLE (71335-2242-3) 18 capsule2023-09-22NoNoHistorical
71335-2242-47133522420490 CAPSULE in 1 BOTTLE (71335-2242-4) 90 capsule2023-09-22NoNoHistorical
71335-2242-571335224205100 CAPSULE in 1 BOTTLE (71335-2242-5) 100 capsule2023-09-22NoNoHistorical
71335-2242-6713352242066 CAPSULE in 1 BOTTLE (71335-2242-6) 6 capsule2023-09-22NoNoHistorical
71335-2242-77133522420760 CAPSULE in 1 BOTTLE (71335-2242-7) 60 capsule2023-09-22NoNoHistorical
71335-2242-871335224208180 CAPSULE in 1 BOTTLE (71335-2242-8) 180 capsule2023-09-22NoNoHistorical
71335-2242-97133522420910 CAPSULE in 1 BOTTLE (71335-2242-9) 10 capsule2023-09-22NoNoHistorical