Home NDC 64543-118-90 Symax Duotab
Product NDC 64543-118
Requested package NDC 64543-118-90
11-digit product format 645430118
Labeler code 64543
Product ID 64543-118_edfed750-effe-3cfa-e053-2995a90a56c8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hyoscyamine Sulfate
Dosage form TABLET, MULTILAYER, EXTENDED RELEASE
Route ORAL
Labeler Capellon Pharmaceuticals, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2009-11-07
Marketing end 0000-00-00
Substance HYOSCYAMINE SULFATE
Active strength 0 mg/1
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYOSCYAMINE SULFATE ACTIVE INGREDIENT F2R8V82B84 SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC] 2 HYOSCYAMINE ACTIVE MOIETY PX44XO846X SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC] 2 CALCIUM PHOSPHATE INACTIVE INGREDIENT 97Z1WI3NDX SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC] 2 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC] 2 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 SYMAX DUOTAB (HYOSCYAMINE SULFATE) TABLET, MULTILAYER, EXTENDED RELEASE [CAPELLON PHARMACEUTICALS, LLC] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 64543-118-90 64543011890 90 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (64543-118-90) 2009-11-07 0000-00-00 No No Current