Hyoscyamine Sulfate SL

Product NDC
67296-2300
11-digit product format
672962300
Labeler code
67296
Product ID
67296-2300_5847561a-3d44-6ba3-e063-6294a90ae0be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hyoscyamine sulfate
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Redpharm Drug
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-05-19
Substance
HYOSCYAMINE SULFATE
Active strength
.125 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Hyoscyamine Sulfate SL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYOSCYAMINE SULFATE.125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F2R8V82B84Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046982Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
584755e4-fea9-4827-e063-6394a90a4a0aAvailable on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hyoscyamine Sulfate SLHYOSCYAMINE SULFATERedpharm Drug584755e4-fea9-4827-e063-6394a90a4a0a2026-08-05Warnings, Adverse reactionsExact identifier
ndc (product): 67296-2300

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-2300-16729623000110 TABLET in 1 BOTTLE (67296-2300-1) 10 tablet2011-05-19NoNoCurrent