Prescription drug · UNAPPROVED DRUG OTHER
Hyoscyamine Sulfate NDC 63561-0203
Hyoscyamine sulfate .125 mg/1 · Tablet · Oral · Granulation Technology, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63561-0203-1 | 6356102030163561020301 | 100 TABLET in 1 BOTTLE (63561-0203-1)Marketed from Jul 27, 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
- Route
- Oral
- Labeler
- Granulation Technology, Inc.NDC labeler code 63561
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 63561-0203_57b12b25-adeb-c9bc-e063-6394a90aa925SPL ID 57b12b25-adeb-c9bc-e063-6394a90aa925SPL set ID 57b12b25-adea-c9bc-e063-6394a90aa925RxCUI 1047905UNII F2R8V82B84UPC 0363561020314
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
N463561020301followed by a unit qualifier and the quantityPackage 63561-0203-01. 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)
INDICATION AND USAGE Hyoscyamine Sulfate 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 bladder and neurogenic bowe…
Excerpt only. Read the full label for complete information.
About NDC 63561-0203
- What is NDC 63561-0203?
- 63561-0203 is the product NDC for Hyoscyamine Sulfate, Hyoscyamine sulfate .125 mg/1 tablet, listed with the FDA by Granulation Technology, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hyoscyamine Sulfate.
- What is the active ingredient?
- Hyoscyamine sulfate.
- Who is the labeler?
- Granulation Technology, Inc., NDC labeler code 63561. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hyoscyamine Sulfate?
- 28 other product NDCs are listed under this name. See all Hyoscyamine Sulfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hyoscyamine Sulfate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hyoscyamine Sulfate | Hyoscyamine sulfate .125 mg/1 | Tablet, Orally disintegratingOral | Granulation Technology, Inc. | 63561-0197 | 63561-0197-01 |
| Hyoscyamine Sulfate | Hyoscyamine sulfate .125 mg/1 | Tablet, Orally disintegratingOral | PD-Rx Pharmaceuticals, Inc. | 72789-563 | 72789-0563-01 |
| Hyoscyamine Sulfate | Hyoscyamine sulfate .125 mg/1 | TabletSublingual | Granulation Technology, Inc. | 63561-0202 | 63561-0202-01 |
| Hyoscyamine Sulfate | Hyoscyamine sulfate .125 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4436 | 70518-4436-00 |
| Hyoscyamine Sulfate | Hyoscyamine sulfate .125 mg/1 | TabletOral | Westminster Pharmaceuticals, LLC | 69367-677 | 69367-0677-01 |
| Hyoscyamine Sulfate | Hyoscyamine sulfate .125 mg/1 | TabletOral | Proficient Rx LP | 82804-965 | 82804-0965-3082804-0965-6082804-0965-64+3 more |
| Hyoscyamine sulfate | Hyoscyamine sulfate .125 mg/1 | Tablet, Orally disintegratingOral | Chartwell RX, LLC | 62135-858 | 62135-0858-12 |
| Hyoscyamine Sulfate | Hyoscyamine sulfate .375 mg/1 | Tablet, Extended releaseOral | Patrin Pharma, Inc. | 39328-052 | 39328-0052-10 |
| Hyoscyamine Sulfate | Hyoscyamine sulfate .125 mg/1 | Tablet, Orally disintegratingOral | Patrin Pharma, Inc. | 39328-049 | 39328-0049-10 |
| Hyoscyamine Sulfate | Hyoscyamine sulfate .125 mg/1 | TabletOral | Patrin Pharma, Inc. | 39328-050 | 39328-0050-10 |