SOLOSEC

Product NDC
27437-051
11-digit product format
274370051
Labeler code
27437
Product ID
27437-051_fe8dadfb-2b46-433c-b3fa-9d9c3d0548b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
secnidazole
Dosage form
GRANULE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
NDA209363
Marketing category
NDA
Marketing start
2017-10-30
Marketing end
0000-00-00
Substance
SECNIDAZOLE
Active strength
2 g/4.8g
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
27437-051-012025-07-29C16284748780-13b156c62-2dce-fb37-e063-e6dba90a4e07551e43d5-f700-4d6e-8029-026f8a8932ff
27437-051-022025-07-29C16284748780-13b156c62-2dce-fb37-e063-e6dba90a4e07551e43d5-f700-4d6e-8029-026f8a8932ff

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27437-051-01EA - Each27437-051be64cd9a-142e-453d-af0f-7ade7cef5d4612018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27437-051SOLOSEC (SECNIDAZOLE) GRANULE [LUPIN PHARMACEUTICALS, INC.]14Legacy NDC20220727_551e43d5-f700-4d6e-8029-026f8a8932ff.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27437-051-01274370051011 PACKET in 1 BOX, UNIT-DOSE (27437-051-01) > 2 g in 1 PACKET1 packet2017-10-300000-00-00NoNoCurrent
27437-051-02274370051021 PACKET in 1 BOX, UNIT-DOSE (27437-051-02) > 2 g in 1 PACKET1 packet2019-03-190000-00-00NoNoCurrent
27437-051-05274370051055 BOX, UNIT-DOSE in 1 CARTON (27437-051-05) > 1 PACKET in 1 BOX, UNIT-DOSE (27437-051-02) > 2 g in 1 PACKET2019-03-190000-00-00NoNoCurrent
27437-051-122743700511212 BOX, UNIT-DOSE in 1 CARTON (27437-051-12) > 1 PACKET in 1 BOX, UNIT-DOSE (27437-051-01) > 2 g in 1 PACKET2017-10-300000-00-00NoNoCurrent