Prescription drug · UNAPPROVED DRUG OTHER
Hyosyne (Hyoscyamine sulfate) NDC 54838-506
Hyoscyamine sulfate .125 mg/mL · Solution/ drops · Oral · Lannett Company, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54838-506-15 | 5483805061554838050615 | 15 mL in 1 BOTTLE, PLASTIC (54838-506-15)Marketed from Oct 1, 1997 |
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)
- Hyosyne
- Generic name (nonproprietary)
- hyoscyamine sulfate
- Active ingredients
- Hyoscyamine sulfate — .125 mg/mL
- Dosage form
- Solution/ drops
- Route
- Oral
- Labeler
- Lannett Company, Inc.NDC labeler code 54838
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 54838-506_d9932ae0-7713-4291-9884-7b233cdb2c9fSPL ID d9932ae0-7713-4291-9884-7b233cdb2c9fSPL set ID 38f12473-08e0-4970-a6ef-a825cc7de8d8RxCUI 1047895UNII 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
N454838050615followed by a unit qualifier and the quantityPackage 54838-0506-15. 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 is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, 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 bowel disturb…
Excerpt only. Read the full label for complete information.
About NDC 54838-506
- What is NDC 54838-506?
- 54838-506 is the product NDC for Hyosyne (hyoscyamine sulfate), Hyoscyamine sulfate .125 mg/mL solution/ drops, listed with the FDA by Lannett Company, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hyosyne (Hyoscyamine Sulfate).
- What is the active ingredient?
- Hyoscyamine sulfate.
- Who is the labeler?
- Lannett Company, Inc., NDC labeler code 54838. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hyosyne?
- 3 other product NDCs are listed under this name. See all Hyosyne NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hyosyne products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hyosynehyoscyamine sulfate | Hyoscyamine sulfate .125 mg/5mL | ElixirOral | ATLANTIC BIOLOGICALS CORP. | 17856-0511 | 17856-0511-02 |
| Hyosynehyoscyamine sulfate | Hyoscyamine sulfate .125 mg/5mL | ElixirOral | ATLANTIC BIOLOGICALS CORP. | 17856-0514 | 17856-0514-05 |
| Hyosynehyoscyamine sulfate | Hyoscyamine sulfate .125 mg/5mL | ElixirOral | Lannett Company, Inc. | 54838-511 | 54838-0511-80 |