Hyoscyamine Sulfate

Product NDC
62559-423
11-digit product format
625590423
Labeler code
62559
Product ID
62559-423_1f3b6482-bdac-411a-8eee-561674ac224e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-02-15
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
62559-423-01Hyoscyamine Sulfate100 in 1 BOTTLETABLET, EXTENDED RELEASE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-423-01EA - Each62559-4237bc03ee1-f1ec-4a33-9b0e-d823c06260cc12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-423HYOSCYAMINE SULFATE TABLET, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20240215_3859133e-88bd-4dd5-90a0-82b64347f1db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046770hyoscyamine sulfate 0.375 MG 12HR Extended Release Oral TabletPSN3859133e-88bd-4dd5-90a0-82b64347f1db2
104677012 HR hyoscyamine sulfate 0.375 MG Extended Release Oral TabletSCD3859133e-88bd-4dd5-90a0-82b64347f1db2
1046770hyoscyamine sulfate 0.375 MG 12 HR Extended Release Oral TabletSY3859133e-88bd-4dd5-90a0-82b64347f1db2
1046770hyoscyamine sulfate 375 MCG 12 HR Extended Release Oral TabletSY3859133e-88bd-4dd5-90a0-82b64347f1db2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62559-423-0162559042301100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62559-423-01) 2024-02-15NoNoCurrent