FDA.reportPublic FDA data

Hyoscyamine Sulfate

Product NDC
62135-511
11-digit product format
621350511
Labeler code
62135
Product ID
62135-511_22f63e6a-d1c4-1057-e063-6394a90a0721
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
ELIXIR
Route
ORAL
Labeler
Chartwell RX, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-07-20
Substance
HYOSCYAMINE SULFATE
Active strength
.125 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYOSCYAMINE SULFATE.125 mg/5mL

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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046982Internal RxNorm lookup
1046985Internal RxNorm lookup
1047881Internal RxNorm lookup
1047895Internal RxNorm lookup
1047905Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
526399a7-03ea-4d09-8dcd-d5cb012ab5c5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-511-47Hyoscyamine Sulfate473 mL in 1 BOTTLEELIXIR4735

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-511-47ML - Milliliter62135-511ed17d9d1-741d-441c-864c-09dd1753c89a12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-511HYOSCYAMINE SULFATE ELIXIR HYOSCYAMINE SULFATE SOLUTION HYOSCYAMINE SULFATE TABLET HYOSCYAMINE SULFATE TABLET, ORALLY DISINTEGRATING HYOSCYAMINE SULFATE SUBLINGUAL (HYOSCYAMINE SULFATE) TABLET [CHARTWELL RX, LLC]5Current NDC, Legacy NDC, 1 package rows20240927_526399a7-03ea-4d09-8dcd-d5cb012ab5c5.zip

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 SulfateHYOSCYAMINE SULFATEChartwell RX, LLC526399a7-03ea-4d09-8dcd-d5cb012ab5c52024-09-25Warnings, Adverse reactionsExact identifier
ndc (product): 62135-511

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046985hyoscyamine sulfate 0.125 MG Disintegrating Oral TabletPSN526399a7-03ea-4d09-8dcd-d5cb012ab5c55
1047895hyoscyamine sulfate 0.125 MG in 1 mL Oral SolutionPSN526399a7-03ea-4d09-8dcd-d5cb012ab5c55
1047881hyoscyamine sulfate 0.125 MG in 5 mL Oral SolutionPSN526399a7-03ea-4d09-8dcd-d5cb012ab5c55
1047905hyoscyamine sulfate 0.125 MG Oral TabletPSN526399a7-03ea-4d09-8dcd-d5cb012ab5c55
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletPSN526399a7-03ea-4d09-8dcd-d5cb012ab5c55
1047881hyoscyamine sulfate 0.025 MG/ML Oral SolutionSCD526399a7-03ea-4d09-8dcd-d5cb012ab5c55
1046985hyoscyamine sulfate 0.125 MG Disintegrating Oral TabletSCD526399a7-03ea-4d09-8dcd-d5cb012ab5c55
1047905hyoscyamine sulfate 0.125 MG Oral TabletSCD526399a7-03ea-4d09-8dcd-d5cb012ab5c55
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletSCD526399a7-03ea-4d09-8dcd-d5cb012ab5c55
1047895hyoscyamine sulfate 0.125 MG/ML Oral SolutionSCD526399a7-03ea-4d09-8dcd-d5cb012ab5c55
1047895hyoscyamine sulfate 0.125 MG per 1 ML Oral SolutionSY526399a7-03ea-4d09-8dcd-d5cb012ab5c55
1047881hyoscyamine sulfate 0.125 MG per 5 ML Oral SolutionSY526399a7-03ea-4d09-8dcd-d5cb012ab5c55
1046982hyoscyamine sulfate SL 0.125 Disintegrating Sublingual TabletSY526399a7-03ea-4d09-8dcd-d5cb012ab5c55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-511-4762135051147473 mL in 1 BOTTLE (62135-511-47) 473 ml2022-07-200000-00-00NoNoCurrent