FDA.reportPublic FDA data

Progesterone

Product NDC
71335-1990
11-digit product format
713351990
Labeler code
71335
Product ID
71335-1990_e7402978-31d9-47fa-b55d-313fec37e274
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
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROGESTERONE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4G7DS2Q64Y

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
71335-1990-0Progesterone120 in 1 BOTTLECAPSULE120104
71335-1990-1Progesterone30 in 1 BOTTLECAPSULE30104
71335-1990-2Progesterone28 in 1 BOTTLECAPSULE28104
71335-1990-3Progesterone18 in 1 BOTTLECAPSULE18104
71335-1990-4Progesterone90 in 1 BOTTLECAPSULE90104
71335-1990-5Progesterone100 in 1 BOTTLECAPSULE100104
71335-1990-6Progesterone6 in 1 BOTTLECAPSULE6104
71335-1990-7Progesterone60 in 1 BOTTLECAPSULE60104
71335-1990-8Progesterone180 in 1 BOTTLECAPSULE180104
71335-1990-9Progesterone10 in 1 BOTTLECAPSULE10104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1990PROGESTERONE CAPSULE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20240602_74a7619a-8f74-4889-96f6-5bae478543e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312641progesterone 200 MG Oral CapsulePSN74a7619a-8f74-4889-96f6-5bae478543e8104
312641progesterone 200 MG Oral CapsuleSCD74a7619a-8f74-4889-96f6-5bae478543e8104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1990-071335199000120 CAPSULE in 1 BOTTLE (71335-1990-0) 120 capsule2024-05-31NoNoCurrent
71335-1990-17133519900130 CAPSULE in 1 BOTTLE (71335-1990-1) 30 capsule2021-11-190000-00-00NoNoCurrent
71335-1990-27133519900228 CAPSULE in 1 BOTTLE (71335-1990-2) 28 capsule2024-05-310000-00-00NoNoCurrent
71335-1990-37133519900318 CAPSULE in 1 BOTTLE (71335-1990-3) 18 capsule2021-12-270000-00-00NoNoCurrent
71335-1990-47133519900490 CAPSULE in 1 BOTTLE (71335-1990-4) 90 capsule2021-11-100000-00-00NoNoCurrent
71335-1990-571335199005100 CAPSULE in 1 BOTTLE (71335-1990-5) 100 capsule2024-05-310000-00-00NoNoCurrent
71335-1990-6713351990066 CAPSULE in 1 BOTTLE (71335-1990-6) 6 capsule2024-05-310000-00-00NoNoCurrent
71335-1990-77133519900760 CAPSULE in 1 BOTTLE (71335-1990-7) 60 capsule2024-05-310000-00-00NoNoCurrent
71335-1990-871335199008180 CAPSULE in 1 BOTTLE (71335-1990-8) 180 capsule2024-05-31NoNoCurrent
71335-1990-97133519900910 CAPSULE in 1 BOTTLE (71335-1990-9) 10 capsule2024-05-31NoNoCurrent