Home NDC 68220-118 NuLev
Product NDC 68220-118
11-digit product format 682200118
Labeler code 68220
Product ID 68220-118_f00e6293-f050-49d1-9332-b992c2f935a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hyoscyamine sulfate
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Viatris Specialty LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2008-12-01
Substance HYOSCYAMINE SULFATE
Active strength .125 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68220-118-10 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68220-118-10 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68220-118-10 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68220-118-10 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68220-118-10 1332a3947898…d4bfe170f9cd…
Additional Listing Data#
Finished product Yes
Brand name base NuLev
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYOSCYAMINE SULFATE .125 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F2R8V82B84 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1046985 Internal RxNorm lookup 1242705 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68220-118-10 NuLev 100 in 1 BOTTLE TABLET, CHEWABLE 100 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68220-118 NULEV (HYOSCYAMINE SULFATE) TABLET, CHEWABLE [ALAVEN PHARMACEUTICAL LLC] 4 Current NDC, Legacy NDC, 1 package rows 20241103_ae2a78b2-b811-11e2-9e96-0800200c9a66.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NuLev HYOSCYAMINE SULFATE Viatris Specialty LLC ae2a78b2-b811-11e2-9e96-0800200c9a66 2025-07-15 Warnings, Adverse reactions Exact identifier ndc (product): 68220-118
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68220-118-10 68220011810 100 TABLET, CHEWABLE in 1 BOTTLE (68220-118-10) 2008-12-01 0000-00-00 No No Current