What is NDC 71269-040?

71269-040 is the product NDC for Tuxarin, Codeine phosphate 54.3 mg/1; Chlorpheniramine maleate 8 mg/1 tablet, extended release, listed with the FDA by Mainpointe Pharmaceuticals. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Tuxarin (Codeine phosphate and chlorpheniramine maleate).

What is the active ingredient?

Codeine phosphate, Chlorpheniramine maleate.

Mainpointe Pharmaceuticals, NDC labeler code 71269. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tuxarin?

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.

Tuxarin NDC 71269-040 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71269-040Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71269-0040Add 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 NDC	11-digit (billing)	Package	Copy
71269-040-10	71269004010	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-10)Marketed from Oct 15, 2018
71269-040-30	71269004030	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-30)Marketed from Oct 15, 2018

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): Tuxarin
Generic name (nonproprietary): codeine phosphate and chlorpheniramine maleate
Active ingredients: Codeine phosphate — 54.3 mg/1Chlorpheniramine maleate — 8 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Mainpointe PharmaceuticalsNDC labeler code 71269
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 206323
Marketing start: Oct 15, 2018
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Full Opioid Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 71269-040_c64324ef-f77f-4467-844a-711a6b305582SPL ID c64324ef-f77f-4467-844a-711a6b305582SPL set ID a7cfab67-6087-4ab4-b7cd-4f9295413180RxCUI 1664543, 2099286UNII GSL05Y1MN6, V1Q0O9OJ9ZUPC 0371269040107
Pharmacologic class: Histamine-1 Receptor Antagonist; Opioid 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

N471269004010 followed by a unit qualifier and the quantity

Package 71269-0040-10. 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 Jan 10, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

TUXARIN ER is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. TUXARIN ER is a combination of codeine, an opioid agonist; and chlorpheniramine, a histamine-1 (H 1 ) receptor antagonist, indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. ( 1 ) Important Limitations of Use ( 1 ) Not indicated for pediatric patients under 18 years of age. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve TUXARIN ER for use in adult patients for whom …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71269-040

What is NDC 71269-040?: 71269-040 is the product NDC for Tuxarin, Codeine phosphate 54.3 mg/1; Chlorpheniramine maleate 8 mg/1 tablet, extended release, listed with the FDA by Mainpointe Pharmaceuticals. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tuxarin (Codeine phosphate and chlorpheniramine maleate).
What is the active ingredient?: Codeine phosphate, Chlorpheniramine maleate.
Who is the labeler?: Mainpointe Pharmaceuticals, NDC labeler code 71269. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tuxarin?: 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.