NDC codes

FDA NDC Directory
Product NDC (as listed)62332-051Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62332-0051Add 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
62332-051-10623320051106233200511010 TABLET in 1 BLISTER PACK (62332-051-10)Marketed from May 23, 2016
62332-051-30623320051306233200513030 TABLET in 1 BOTTLE (62332-051-30)Marketed from May 23, 2016
62332-051-90623320051906233200519090 TABLET in 1 BOTTLE (62332-051-90)Marketed from May 23, 2016
62332-051-9162332005191623320051911000 TABLET in 1 BOTTLE (62332-051-91)Marketed from May 23, 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)
Irbesartan and Hydrochlorothiazide
Generic name (nonproprietary)
irbesartan and hydrochlorothiazide
Active ingredients
Irbesartan — 150 mg/1Hydrochlorothiazide — 12.5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Alembic Pharmaceuticals Inc.NDC labeler code 62332
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091370
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers
Product ID 62332-051_08cf62b6-c618-4e6a-877a-4e26ca6e91eeSPL ID 08cf62b6-c618-4e6a-877a-4e26ca6e91eeSPL set ID e842fa14-b18e-4463-9bf1-a1c8700fe33cRxCUI 310792, 310793, 485471UNII 0J48LPH2TH, J0E2756Z7NUPC 0362332052301, 0362332051304, 0362332053308
Pharmacologic class
Angiotensin 2 Receptor Blocker; Thiazide Diuretic

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

N462332005110 followed by a unit qualifier and the quantity

Package 62332-0051-10. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE Irbesartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension. Irbesartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Irbesartan and hydrochlorothiazide tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of irbesartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as stro…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62332-051

What is NDC 62332-051?
62332-051 is the product NDC for Irbesartan and Hydrochlorothiazide, Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Inc.. It has 4 package NDCs, 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?
Alembic Pharmaceuticals Inc., NDC labeler code 62332. 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?
28 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 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/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-21529300-0215-1029300-0215-1329300-0215-19
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 300 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-05362332-0053-1062332-0053-3062332-0053-90+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 coatedOralAurobindo Pharma Limited65862-63165862-0631-0565862-0631-3065862-0631-90+1 more
Irbesartan and HydrochlorothiazideIrbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralBryant Ranch Prepack72162-231772162-2317-0372162-2317-09

All 29 Irbesartan and Hydrochlorothiazide NDCs

Other NDCs under ANDA 091370

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

FDA NDC Directory listings under ANDA 091370
ProductStrengthForm · routeLabelerProduct NDC
Irbesartan and HydrochlorothiazideIrbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralAlembic Pharmaceuticals Limited46708-442
Irbesartan and HydrochlorothiazideIrbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralAlembic Pharmaceuticals Limited46708-443
Irbesartan and HydrochlorothiazideIrbesartan 300 mg/1; Hydrochlorothiazide 25 mg/1TabletOralAlembic Pharmaceuticals Limited46708-444
Irbesartan and HydrochlorothiazideIrbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-052
Irbesartan and HydrochlorothiazideIrbesartan 300 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-053

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