Prescription drug · UNAPPROVED DRUG OTHER
Hyoscyamine Sulfate SL (Hyoscyamine sulfate) NDC 69367-678
Hyoscyamine sulfate .125 mg/1 · Tablet · Oral · Westminster Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69367-678-01 | 6936706780169367067801 | 100 TABLET in 1 BOTTLE (69367-678-01)Marketed from Apr 2, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 SLSuffix: SL
- Generic name (nonproprietary)
- hyoscyamine sulfate
- Active ingredients
- Hyoscyamine sulfate — .125 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Westminster Pharmaceuticals, LLCNDC labeler code 69367
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 69367-678_1c473f01-dccd-4be7-bb0b-9a028f90fd22SPL ID 1c473f01-dccd-4be7-bb0b-9a028f90fd22SPL set ID 2b7d1604-3e95-4fc9-a65d-2c06ace16009RxCUI 1046982UNII 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
N469367067801followed by a unit qualifier and the quantityPackage 69367-0678-01. 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 Sublingual 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 neu…
Excerpt only. Read the full label for complete information.
About NDC 69367-678
- What is NDC 69367-678?
- 69367-678 is the product NDC for Hyoscyamine Sulfate SL (hyoscyamine sulfate), Hyoscyamine sulfate .125 mg/1 tablet, listed with the FDA by Westminster Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hyoscyamine Sulfate SL (Hyoscyamine Sulfate).
- What is the active ingredient?
- Hyoscyamine sulfate.
- Who is the labeler?
- Westminster Pharmaceuticals, LLC, NDC labeler code 69367. 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 SL?
- 4 other product NDCs are listed under this name. See all Hyoscyamine Sulfate SL 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 SL 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 SLhyoscyamine sulfate | Hyoscyamine sulfate .125 mg/1 | TabletSublingual | Acella Pharmaceuticals, LLC | 42192-339 | 42192-0339-01 |
| Hyoscyamine Sulfate SLhyoscyamine sulfate | Hyoscyamine sulfate .125 mg/1 | TabletSublingual | Redpharm Drug | 67296-2300 | 67296-2300-0167296-2300-02 |
| Hyoscyamine Sulfate SLhyoscyamine sulfate | Hyoscyamine sulfate .125 mg/1 | TabletSublingual | Bryant Ranch Prepack | 71335-1159 | 71335-1159-0071335-1159-0171335-1159-02+7 more |
| Hyoscyamine Sulfate SLhyoscyamine sulfate | Hyoscyamine sulfate .125 mg/1 | TabletSublingual | Sportpharm LLC | 85766-296 | 85766-0296-0185766-0296-2885766-0296-30+2 more |