Home NDC 64543-111 Symax SL
Product NDC 64543-111
11-digit product format 645430111
Labeler code 64543
Product ID 64543-111_edfec913-38b9-6ac6-e053-2a95a90a6687
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hyoscyamine Sulfate
Dosage form TABLET, ORALLY DISINTEGRATING
Route ORAL
Labeler Capellon Pharmaceuticals, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 1996-09-01
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 · 24 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64543-111-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64543-111-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64543-111-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64543-111-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64543-111-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64543-111-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64543-111-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64543-111-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64543-111-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64543-111-01 ad56d346431e…cc804d4bbf1e…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 64543-111-01 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 64543-111-01 557ba5c1ecfa…9c80585c8c6e…
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 SL (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [CAPELLON PHARMACEUTICALS, LLC] 3 HYOSCYAMINE ACTIVE MOIETY PX44XO846X SYMAX SL (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [CAPELLON PHARMACEUTICALS, LLC] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G SYMAX SL (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [CAPELLON PHARMACEUTICALS, LLC] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD SYMAX SL (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [CAPELLON PHARMACEUTICALS, LLC] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SYMAX SL (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [CAPELLON PHARMACEUTICALS, LLC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SYMAX SL (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [CAPELLON PHARMACEUTICALS, LLC] 3 MANNITOL INACTIVE INGREDIENT 3OWL53L36A SYMAX SL (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [CAPELLON PHARMACEUTICALS, LLC] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SYMAX SL (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [CAPELLON PHARMACEUTICALS, LLC] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SYMAX SL (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [CAPELLON PHARMACEUTICALS, LLC] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 64543-111-01 64543011101 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (64543-111-01) 1996-09-01 0000-00-00 No No Current