NDC codes

FDA NDC Directory
Product NDC (as listed)58809-186Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58809-0186Add 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
58809-186-30588090186305880901863030 TABLET in 1 BOTTLE (58809-186-30)Marketed from Dec 1, 2015

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)
TexaClear
Generic name (nonproprietary)
allergy relief
Active ingredients
Chlophedianol hydrochloride — 25 mg/1Pyrilamine maleate — 50 mg/1
Dosage form
Tablet
Route
Oral
Labeler
GM Pharmaceuticals, INCNDC labeler code 58809
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 12
Marketing start
Listing expires
Identifiers
Product ID 58809-186_47e5a8c0-5221-65e9-e063-6294a90a443bSPL ID 47e5a8c0-5221-65e9-e063-6294a90a443bSPL set ID 2a06e00a-0887-4386-e054-00144ff88e88RxCUI 1735487UNII 69QQ58998Y, R35D29L3ZAUPC 0358809186303

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

N458809018630 followed by a unit qualifier and the quantity

Package 58809-0186-30. 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 upper respiratory allergies: runny nose itchy, watery eyes itching of the nose or throat sneezing cough due to minor throat and bronchial irritation

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58809-186

What is NDC 58809-186?
58809-186 is the product NDC for TexaClear (allergy relief), Chlophedianol hydrochloride 25 mg/1; Pyrilamine maleate 50 mg/1 tablet, listed with the FDA by GM Pharmaceuticals, INC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
TexaClear (Allergy Relief).
What is the active ingredient?
Chlophedianol hydrochloride, Pyrilamine maleate.
Who is the labeler?
GM Pharmaceuticals, INC, NDC labeler code 58809. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for TexaClear?
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.

Other NDCs under M 12

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 12
ProductStrengthForm · routeLabelerProduct NDC
TexaClear Kids Allergychlophedianol hcl pyrilamine maleateChlophedianol hydrochloride 12.5 mg/30mL; Pyrilamine maleate 25 mg/30mLLiquidOralGM Pharmaceuticals, Inc.58809-925

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