FDA.reportPublic FDA data

PROGESTERONE

Product NDC
71335-9739
11-digit product format
713359739
Labeler code
71335
Product ID
71335-9739_3547019b-bb80-50a6-e063-6394a90ae40c
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
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
71335-9739-1PROGESTERONE30 in 1 BOTTLECAPSULE30102
71335-9739-2PROGESTERONE8 in 1 BOTTLECAPSULE8102
71335-9739-3PROGESTERONE100 in 1 BOTTLECAPSULE100102
71335-9739-4PROGESTERONE10 in 1 BOTTLECAPSULE10102
71335-9739-5PROGESTERONE90 in 1 BOTTLECAPSULE90102
71335-9739-6PROGESTERONE60 in 1 BOTTLECAPSULE60102
71335-9739-7PROGESTERONE12 in 1 BOTTLECAPSULE12102
71335-9739-8PROGESTERONE180 in 1 BOTTLECAPSULE180102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9739-1EA - Each71335-9739541d62ca-07a5-47cf-9ff5-f0e80ff6c1bb12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9739PROGESTERONE CAPSULE [BRYANT RANCH PREPACK]102Current NDC, 8 package rows20250519_0aeb0f0f-2749-416b-942f-83950200fd75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260243progesterone 100 MG Oral CapsulePSN0aeb0f0f-2749-416b-942f-83950200fd75102
260243progesterone 100 MG Oral CapsuleSCD0aeb0f0f-2749-416b-942f-83950200fd75102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9739-17133597390130 CAPSULE in 1 BOTTLE (71335-9739-1) 30 capsule2023-07-19NoNoCurrent
71335-9739-2713359739028 CAPSULE in 1 BOTTLE (71335-9739-2) 8 capsule2024-04-05NoNoCurrent
71335-9739-371335973903100 CAPSULE in 1 BOTTLE (71335-9739-3) 100 capsule2023-12-21NoNoCurrent
71335-9739-47133597390410 CAPSULE in 1 BOTTLE (71335-9739-4) 10 capsule2024-04-05NoNoCurrent
71335-9739-57133597390590 CAPSULE in 1 BOTTLE (71335-9739-5) 90 capsule2023-09-11NoNoCurrent
71335-9739-67133597390660 CAPSULE in 1 BOTTLE (71335-9739-6) 60 capsule2023-09-11NoNoCurrent
71335-9739-77133597390712 CAPSULE in 1 BOTTLE (71335-9739-7) 12 capsule2024-02-27NoNoCurrent
71335-9739-871335973908180 CAPSULE in 1 BOTTLE (71335-9739-8) 180 capsule2024-04-05NoNoCurrent