NDC codes

FDA NDC Directory
Product NDC (as listed)0485-0206Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00485-0206Add 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
0485-0206-160048502061600485020616473 mL in 1 BOTTLE, PLASTIC (0485-0206-16)Marketed from Mar 7, 2011

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)
Rynex Pse
Generic name (nonproprietary)
brompheniramine maleate and pseudoephedrine hydrochloride
Active ingredients
Brompheniramine maleate — 1 mg/5mLPseudoephedrine hydrochloride — 15 mg/5mL
Dosage form
Liquid
Route
Oral
Labeler
EDWARDS PHARMACEUTICALS, INC.NDC labeler code 0485
Product type
Over-the-counter drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)
Identifiers
Product ID 0485-0206_4c48242c-1746-1a49-e063-6294a90ac81dSPL ID 4c48242c-1746-1a49-e063-6294a90ac81dSPL set ID 2f2d9b5a-f66b-4928-8d43-402ef9efcfdfRxCUI 1098498UNII IXA7C9ZN03, 6V9V2RYJ8N
Pharmacologic class
alpha-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

N400485020616 followed by a unit qualifier and the quantity

Package 00485-0206-16. 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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0485-0206

What is NDC 0485-0206?
0485-0206 is the product NDC for Rynex Pse, Brompheniramine maleate 1 mg/5mL; Pseudoephedrine hydrochloride 15 mg/5mL liquid, listed with the FDA by EDWARDS PHARMACEUTICALS, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Rynex Pse (BROMPHENIRAMINE MALEATE and PSEUDOEPHEDRINE HYDROCHLORIDE).
What is the active ingredient?
Brompheniramine maleate, Pseudoephedrine hydrochloride.
Who is the labeler?
EDWARDS PHARMACEUTICALS, INC., NDC labeler code 0485. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Rynex Pse?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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