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 Identifiers#

Field, Values table
FieldValues
UniiF2R8V82B84
Rxcui1046982, 1046985, 1047881, 1047895, 1047905

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 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

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