Hyoscyamine sulfate

Product NDC
62135-860
11-digit product format
621350860
Labeler code
62135
Product ID
62135-860_1a50af81-4258-aa0d-e063-6394a90a5187
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine sulfate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Chartwell RX, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-06-05
Substance
HYOSCYAMINE SULFATE
Active strength
.375 mg/1
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.375 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF2R8V82B84
Rxcui1046770

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-860-60Hyoscyamine sulfate60 in 1 BOTTLETABLET, EXTENDED RELEASE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-860-60EA - Each62135-86052a587b1-b059-4bff-8c23-591227c0d79912024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-860HYOSCYAMINE SULFATE TABLET, EXTENDED RELEASE [CHARTWELL RX, LLC]1Current NDC, 1 package rows20240608_342edf8e-cca5-4018-9373-0b2e62bc9f4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046770hyoscyamine sulfate 0.375 MG 12HR Extended Release Oral TabletPSN342edf8e-cca5-4018-9373-0b2e62bc9f4b1
104677012 HR hyoscyamine sulfate 0.375 MG Extended Release Oral TabletSCD342edf8e-cca5-4018-9373-0b2e62bc9f4b1
1046770hyoscyamine sulfate 0.375 MG 12 HR Extended Release Oral TabletSY342edf8e-cca5-4018-9373-0b2e62bc9f4b1
1046770hyoscyamine sulfate 375 MCG 12 HR Extended Release Oral TabletSY342edf8e-cca5-4018-9373-0b2e62bc9f4b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-860-606213508606060 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-860-60) 2024-06-05NoNoHistorical