Candesartan Cilexetil NDC 46708-060

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-060Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0060Add 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
46708-060-10	46708006010	100 TABLET in 1 CARTON (46708-060-10)Marketed from Jun 21, 2017
46708-060-30	46708006030	30 TABLET in 1 BOTTLE (46708-060-30)Marketed from Jun 21, 2017
46708-060-90	46708006090	90 TABLET in 1 BOTTLE (46708-060-90)Marketed from Jun 21, 2017

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): Candesartan Cilexetil
Generic name (nonproprietary): candesartan cilexetil
Active ingredients: Candesartan cilexetil — 32 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 209119
Marketing start: Jun 21, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 46708-060_048b90e3-9511-49be-8513-ebd0bde1e03cSPL ID 048b90e3-9511-49be-8513-ebd0bde1e03cSPL set ID d23fe59a-2ad6-4885-a0d8-2239048f05a3RxCUI 639537UNII R85M2X0D68UPC 0346708060305
Pharmacologic class: Angiotensin 2 Receptor Blocker

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

N446708006010 followed by a unit qualifier and the quantity

Package 46708-0060-10. 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 13, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Candesartan cilexetil tablets are an angiotensin II receptor blocker (ARB) indicated for: · Treatment of hypertension in adults and children 1 to <17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1). · Treatment of heart failure (NYHA class II-IV); candesartan cilexetil tablets reduces cardiovascular death and heart failure hospitalization (1.2) 1.1 Hypertension Candesartan cilexetil tablets are indicated for the treatment of hypertension in adults and in children 1 to <17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and n…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209119

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

FDA NDC Directory listings under ANDA 209119
Product	Strength	Form · route	Labeler	Product NDC
Candesartan Cilexetil	Candesartan cilexetil 32 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-060