Solosec

Product NDC
69751-400
11-digit product format
697510400
Labeler code
69751
Product ID
69751-400_4a3aa8e8-bb23-46ce-998d-69dc7c9fb386
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
secnidazole
Dosage form
GRANULE
Route
ORAL
Labeler
Evofem Inc.
Application
NDA209363
Marketing category
NDA
Marketing start
2018-05-31
Substance
SECNIDAZOLE
Active strength
2 g/4.8g
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Solosec
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SECNIDAZOLE2 g/4.8g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR3459K699K
Rxcui1946692, 1946698

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
28be07de-d453-4c9c-bea3-8cd83b2e7204Product name220220125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69751-400-01Solosec2 g in 1 PACKETGRANULE21
69751-400-01Solosec1 in 1 CARTONGRANULE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69751-400SOLOSEC (SECNIDAZOLE) GRANULE [EVOFEM INC.]1Current NDC, 2 package rows20250223_056485b6-8bba-4a21-ae00-cdb4e7ae4bfa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1946692secnidazole 2 GM Oral GranulesPSN056485b6-8bba-4a21-ae00-cdb4e7ae4bfa1
1946698solosec 2 GM Oral GranulesPSN056485b6-8bba-4a21-ae00-cdb4e7ae4bfa1
1946698secnidazole 2000 MG Oral Granules [Solosec]SBD056485b6-8bba-4a21-ae00-cdb4e7ae4bfa1
1946692secnidazole 2000 MG Oral GranulesSCD056485b6-8bba-4a21-ae00-cdb4e7ae4bfa1
1946692secnidazole 2 GM Oral GranulesSY056485b6-8bba-4a21-ae00-cdb4e7ae4bfa1
1946698Solosec 2 GM Oral GranulesSY056485b6-8bba-4a21-ae00-cdb4e7ae4bfa1
1946698Solosec 2000 MG Oral GranulesSY056485b6-8bba-4a21-ae00-cdb4e7ae4bfa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69751-400-01697510400011 PACKET in 1 CARTON (69751-400-01) / 2 g in 1 PACKET1 packet2018-05-31NoNoCurrent