FDA.reportPublic FDA data

Progesterone

Product NDC
71335-1913
11-digit product format
713351913
Labeler code
71335
Product ID
71335-1913_c10b16b4-343d-48ad-b485-af3201f3b045
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Progesterone
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205229
Marketing category
ANDA
Marketing start
2021-01-08
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
71335-1913-1Progesterone30 in 1 BOTTLECAPSULE30103
71335-1913-2Progesterone8 in 1 BOTTLECAPSULE8103
71335-1913-3Progesterone100 in 1 BOTTLECAPSULE100103
71335-1913-4Progesterone10 in 1 BOTTLECAPSULE10103
71335-1913-5Progesterone90 in 1 BOTTLECAPSULE90103
71335-1913-6Progesterone60 in 1 BOTTLECAPSULE60103
71335-1913-7Progesterone12 in 1 BOTTLECAPSULE12103
71335-1913-8Progesterone180 in 1 BOTTLECAPSULE180103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1913PROGESTERONE CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 8 package rows20240602_1ba10f9d-6e91-4954-ac91-23adcf8805b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260243progesterone 100 MG Oral CapsulePSN1ba10f9d-6e91-4954-ac91-23adcf8805b0103
260243progesterone 100 MG Oral CapsuleSCD1ba10f9d-6e91-4954-ac91-23adcf8805b0103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1913-17133519130130 CAPSULE in 1 BOTTLE (71335-1913-1) 30 capsule2021-09-030000-00-00NoNoCurrent
71335-1913-2713351913028 CAPSULE in 1 BOTTLE (71335-1913-2) 8 capsule2024-05-310000-00-00NoNoCurrent
71335-1913-371335191303100 CAPSULE in 1 BOTTLE (71335-1913-3) 100 capsule2024-05-310000-00-00NoNoCurrent
71335-1913-47133519130410 CAPSULE in 1 BOTTLE (71335-1913-4) 10 capsule2024-05-310000-00-00NoNoCurrent
71335-1913-57133519130590 CAPSULE in 1 BOTTLE (71335-1913-5) 90 capsule2021-10-280000-00-00NoNoCurrent
71335-1913-67133519130660 CAPSULE in 1 BOTTLE (71335-1913-6) 60 capsule2022-11-100000-00-00NoNoCurrent
71335-1913-77133519130712 CAPSULE in 1 BOTTLE (71335-1913-7) 12 capsule2022-11-100000-00-00NoNoCurrent
71335-1913-871335191308180 CAPSULE in 1 BOTTLE (71335-1913-8) 180 capsule2024-05-31NoNoHistorical