Unfinished product

This listing is a drug for further processing, not a finished drug product dispensed or administered to patients. It is not normally billed.

NDC codes

FDA NDC Directory
Product NDC (as listed)65862-631Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0631Add 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
65862-631-22658620631222000 TABLET, FILM COATED in 1 BAG (65862-631-22)Marketed from 31-MAR-16

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

Generic name (nonproprietary)
irbesartan and hydrochlorothiazide
Active ingredients
Irbesartan — 300 mg/1Hydrochlorothiazide — 25 mg/1
Dosage form
Tablet, Film coated
Labeler
Aurobindo Pharma LimitedNDC labeler code 65862
Product type
Drug for further processing
Marketing category
Drug for further processing
Marketing start
Listing expires
Identifiers
Product ID 65862-631_a0f7ea09-7dfb-4aaf-a632-72bef0c8e694SPL ID a0f7ea09-7dfb-4aaf-a632-72bef0c8e694

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N465862063122 followed by a unit qualifier and the quantity

Package 65862-0631-22. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 65862-631

What is NDC 65862-631?
65862-631 is the product NDC for Irbesartan and Hydrochlorothiazide, Irbesartan 300 mg/1; Hydrochlorothiazide 25 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Irbesartan and Hydrochlorothiazide.
What is the active ingredient?
Irbesartan, Hydrochlorothiazide.
Who is the labeler?
Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Irbesartan and Hydrochlorothiazide?
25 other product NDCs are listed under this name. See all Irbesartan and Hydrochlorothiazide NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Irbesartan and Hydrochlorothiazide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Irbesartan and HydrochlorothiazideIrbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralREMEDYREPACK INC.70518-155070518-1550-0070518-1550-01
Irbesartan and HydrochlorothiazideIrbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-21529300-0215-1029300-0215-1329300-0215-19
Irbesartan and HydrochlorothiazideIrbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-21629300-0216-1029300-0216-1329300-0216-19
Irbesartan and HydrochlorothiazideIrbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralAlembic Pharmaceuticals Limited46708-44246708-0442-1046708-0442-3046708-0442-90+1 more
Irbesartan and HydrochlorothiazideIrbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralAlembic Pharmaceuticals Limited46708-44346708-0443-1046708-0443-3046708-0443-90+1 more
Irbesartan and HydrochlorothiazideIrbesartan 300 mg/1; Hydrochlorothiazide 25 mg/1TabletOralAlembic Pharmaceuticals Limited46708-44446708-0444-1046708-0444-3046708-0444-90+1 more
Irbesartan and HydrochlorothiazideIrbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-05162332-0051-1062332-0051-3062332-0051-90+1 more
Irbesartan and HydrochlorothiazideIrbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-05262332-0052-1062332-0052-3062332-0052-90+1 more
Irbesartan and HydrochlorothiazideIrbesartan 300 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-05362332-0053-1062332-0053-3062332-0053-90+1 more
Irbesartan and HydrochlorothiazideIrbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralSolco Healthcare US, LLC43547-33043547-0330-0343547-0330-0943547-0330-50

All 26 Irbesartan and Hydrochlorothiazide NDCs

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