NDC codes

FDA NDC Directory
Product NDC (as listed)0485-0208Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00485-0208Add 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
0485-0208-1600485020816473 mL in 1 BOTTLE, PLASTIC (0485-0208-16)Marketed from Jun 1, 2012

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Ed Bron Gp
Generic name (nonproprietary)
guaifenesin and phenylephrine
Active ingredients
Guaifenesin — 100 mg/5mLPhenylephrine hydrochloride — 5 mg/5mL
Dosage form
Liquid
Route
Oral
Product type
Over-the-counter drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha1-Agonists (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
Identifiers
Product ID 0485-0208_423e6598-ff90-d9d4-e063-6294a90a1fbaSPL ID 423e6598-ff90-d9d4-e063-6294a90a1fbaSPL set ID b1fca5aa-d877-45e0-b074-dcbc6af94ee3RxCUI 1358627UNII 495W7451VQ, 04JA59TNSJUPC 0304850208167
Pharmacologic class
Expectorant; alpha-1 Adrenergic Agonist

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

N400485020816 followed by a unit qualifier and the quantity

Package 00485-0208-16. 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)

Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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