Irbesartan and Hydrochlorothiazide NDC 46708-443

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-443Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0443Add 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
46708-443-10	46708044310	10 TABLET in 1 BLISTER PACK (46708-443-10)Marketed from May 23, 2016
46708-443-30	46708044330	30 TABLET in 1 BOTTLE (46708-443-30)Marketed from May 23, 2016
46708-443-90	46708044390	90 TABLET in 1 BOTTLE (46708-443-90)Marketed from May 23, 2016
46708-443-91	46708044391	1000 TABLET in 1 BOTTLE (46708-443-91)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 — 300 mg/1Hydrochlorothiazide — 12.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091370
Marketing start: May 23, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 46708-443_bbfa2906-f126-40a2-a5c4-8cbe19388fccSPL ID bbfa2906-f126-40a2-a5c4-8cbe19388fccSPL set ID 9492a1cd-c012-4b43-931d-235220065e1eRxCUI 310792, 310793, 485471UNII 0J48LPH2TH, J0E2756Z7NUPC 0346708442309, 0346708444303, 0346708443306
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

N446708044310 followed by a unit qualifier and the quantity

Package 46708-0443-10. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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
Product	Strength	Form · route	Labeler	Product NDC
Irbesartan and Hydrochlorothiazide	Irbesartan 300 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-444
Irbesartan and Hydrochlorothiazide	Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-442
Irbesartan and Hydrochlorothiazide	Irbesartan 150 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-051
Irbesartan and Hydrochlorothiazide	Irbesartan 300 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-052
Irbesartan and Hydrochlorothiazide	Irbesartan 300 mg/1; Hydrochlorothiazide 25 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-053