PROGESTERONE

Product NDC
70095-136
11-digit product format
700950136
Labeler code
70095
Product ID
70095-136_5232dd12-1767-7fa2-e063-6294a90a4e70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Progesterone
Dosage form
INSERT
Route
VAGINAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA022057
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2026-04-27
Substance
PROGESTERONE
Active strength
100 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
PROGESTERONE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4G7DS2Q64Y
Rxcui725094

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
70095-136-01PROGESTERONE1 in 1 BLISTER PACKINSERT13
70095-136-02PROGESTERONE21 in 1 CARTONINSERT213
70095-136-03PROGESTERONE1 in 1 CARTONINSERT13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
725094progesterone 100 MG Vaginal TabletPSNfcdde0d0-4329-4725-a76b-684f9d97fe953
725094progesterone 100 MG Vaginal InsertSCDfcdde0d0-4329-4725-a76b-684f9d97fe953

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70095-136-01700950136011 in 1 BLISTER PACKHistorical
70095-136-027009501360221 in 1 CARTONHistorical
70095-136-03700950136031 CARTON in 1 CARTON (70095-136-03) / 21 BLISTER PACK in 1 CARTON (70095-136-02) / 1 INSERT in 1 BLISTER PACK (70095-136-01) 1 carton2026-04-27NoNoHistorical