Prescription drug · UNAPPROVED DRUG OTHER
Hyoscyamine Sulfate NDC 63561-0197
Hyoscyamine sulfate .125 mg/1 · Tablet, Orally disintegrating · Oral · Granulation Technology, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63561-0197-1 | 63561019701 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63561-0197-1)Marketed from Apr 16, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Hyoscyamine Sulfate
- Generic name (nonproprietary)
- hyoscyamine sulfate
- Active ingredients
- Hyoscyamine sulfate — .125 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Granulation Technology, Inc.
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 63561-0197_4f86347a-9346-8ff6-e063-6294a90a59c9SPL ID 4f86347a-9346-8ff6-e063-6294a90a59c9SPL set ID 4f863ae9-d010-b2f5-e063-6394a90a1a95RxCUI 1046985UNII F2R8V82B84
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N463561019701followed by a unit qualifier and the quantityPackage 63561-0197-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Hyoscyamine Sulfate Orally Disintegrating Tablets are effective as adjunctive therapy in the treatment of peptic ulcer. They can also be used to control gastric secretions, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic blad…
Excerpt only. Read the full label for complete information.