Progesterone

Product NDC
43598-350
11-digit product format
435980350
Labeler code
43598
Product ID
43598-350_4b8f3d16-f096-32f0-65f9-230ab8c292b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Progesterone
Dosage form
CAPSULE
Route
ORAL
Labeler
Dr. Reddy�s Laboratories, Inc.
Application
ANDA208801
Marketing category
ANDA
Marketing start
2017-03-25
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROGESTERONE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4G7DS2Q64Y
Rxcui260243, 312641

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43598-350-692020-01-31C16284748780-19d75b9d0-8c77-f424-e053-dadaa90a57ce3788659e-f4ee-7d4f-2ae1-947df971d7bf

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-350-01Progesterone100 in 1 BOTTLECAPSULE1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-350PROGESTERONE CAPSULE [DR. REDDY’S LABORATORIES, INC.]8Current NDC, Legacy NDC, 1 package rows20240316_efded380-02ff-68c9-13e4-47a561ede440.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
260243progesterone 100 MG Oral CapsulePSNefded380-02ff-68c9-13e4-47a561ede4408
312641progesterone 200 MG Oral CapsulePSNefded380-02ff-68c9-13e4-47a561ede4408
260243progesterone 100 MG Oral CapsuleSCDefded380-02ff-68c9-13e4-47a561ede4408
312641progesterone 200 MG Oral CapsuleSCDefded380-02ff-68c9-13e4-47a561ede4408

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-350-0143598035001100 CAPSULE in 1 BOTTLE (43598-350-01) 100 capsule2017-03-250000-00-00NoNoCurrent
43598-350-694359803506912000 CAPSULE in 1 POUCH (43598-350-69)12000 capsule25-MAR-17Current