NDC codes

FDA NDC Directory
Product NDC (as listed)42192-339Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42192-0339Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
42192-339-014219203390142192033901100 TABLET in 1 BOTTLE (42192-339-01)Marketed from May 19, 2011

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 SL
Generic name (nonproprietary)
hyoscyamine sulfate
Active ingredients
Hyoscyamine sulfate — .125 mg/1
Dosage form
Tablet
Route
Sublingual
Labeler
Acella Pharmaceuticals, LLCNDC labeler code 42192
Product type
Prescription drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Identifiers
Product ID 42192-339_40331302-66d2-ddb4-e063-6394a90a8bd9SPL ID 40331302-66d2-ddb4-e063-6394a90a8bd9SPL set ID 8aab1dce-0699-4866-8707-33b4e2177bddRxCUI 1046982UNII F2R8V82B84UPC 0342192339019

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. Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N442192033901 followed by a unit qualifier and the quantity

Package 42192-0339-01. 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 This product may be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. It can also be used to control gastric secretion, visceral spasm and hypermotility in cystitis, pylorospasm and associated abdominal cramps. Along with appropriate analgesics, this product is indicated in symptomatic relief of biliary and renal colic and as a drying agent in the relief of symptoms of acute rhinitis. This product is effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome, acute enterocolitis and other functional gastrointestinal disorders.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42192-339

What is NDC 42192-339?
42192-339 is the product NDC for Hyoscyamine Sulfate SL (hyoscyamine sulfate), Hyoscyamine sulfate .125 mg/1 tablet, listed with the FDA by Acella 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?
Acella Pharmaceuticals, LLC, NDC labeler code 42192. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Hyoscyamine Sulfate SL NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Hyoscyamine Sulfate SLhyoscyamine sulfateHyoscyamine sulfate .125 mg/1TabletOralWestminster Pharmaceuticals, LLC69367-67869367-0678-01
Hyoscyamine Sulfate SLhyoscyamine sulfateHyoscyamine sulfate .125 mg/1TabletSublingualRedpharm Drug67296-230067296-2300-0167296-2300-02
Hyoscyamine Sulfate SLhyoscyamine sulfateHyoscyamine sulfate .125 mg/1TabletSublingualBryant Ranch Prepack71335-115971335-1159-0071335-1159-0171335-1159-02+7 more
Hyoscyamine Sulfate SLhyoscyamine sulfateHyoscyamine sulfate .125 mg/1TabletSublingualSportpharm LLC85766-29685766-0296-0185766-0296-2885766-0296-30+2 more

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