NDC codes

FDA NDC Directory
Product NDC (as listed)58809-925Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58809-0925Add 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
58809-925-085880909250858809092508237 mL in 1 BOTTLE (58809-925-08)Marketed from Jun 15, 2016

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 Kids Allergy
Generic name (nonproprietary)
chlophedianol hcl pyrilamine maleate
Active ingredients
Chlophedianol hydrochloride — 12.5 mg/30mLPyrilamine maleate — 25 mg/30mL
Dosage form
Liquid
Route
Oral
Labeler
GM Pharmaceuticals, Inc.NDC labeler code 58809
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 12
Marketing start
Listing expires
Identifiers
Product ID 58809-925_413912d6-8c4d-3486-e063-6294a90a00bbSPL ID 413912d6-8c4d-3486-e063-6294a90a00bbSPL set ID 3b8a686f-d8e8-56db-e054-00144ff8d46cRxCUI 1808189UNII 69QQ58998Y, R35D29L3ZAUPC 0358809925087

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

N458809092508 followed by a unit qualifier and the quantity

Package 58809-0925-08. 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: itchy nose or throat sneezing itchy, watery eyes runny nose 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 58809-925

What is NDC 58809-925?
58809-925 is the product NDC for TexaClear Kids Allergy (chlophedianol hcl pyrilamine maleate), Chlophedianol hydrochloride 12.5 mg/30mL; Pyrilamine maleate 25 mg/30mL liquid, 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 Kids Allergy (Chlophedianol HCl Pyrilamine Maleate).
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 Kids Allergy?
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
TexaClearallergy reliefChlophedianol hydrochloride 25 mg/1; Pyrilamine maleate 50 mg/1TabletOralGM Pharmaceuticals, INC58809-186

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