Candesartan NDC 33342-116

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-116Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0116Add 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
33342-116-07	33342011607	30 TABLET in 1 CONTAINER (33342-116-07)Marketed from Dec 6, 2016
33342-116-10	33342011610	90 TABLET in 1 CONTAINER (33342-116-10)Marketed from Dec 6, 2016
33342-116-12	33342011612	10 BLISTER PACK in 1 CARTON (33342-116-12) / 10 TABLET in 1 BLISTER PACKMarketed from Dec 6, 2016
33342-116-51	33342011651	300 TABLET in 1 CONTAINER (33342-116-51)Marketed from Dec 6, 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): Candesartan
Generic name (nonproprietary): candesartan
Active ingredients: Candesartan cilexetil — 16 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Macleods Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203813
Marketing start: Dec 6, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 33342-116_4079c843-42ee-4f7a-a4a0-9498ba6cf12dSPL ID 4079c843-42ee-4f7a-a4a0-9498ba6cf12dSPL set ID 8ceb5658-b03c-475d-9ef0-2cd0645191d3RxCUI 153822, 153823, 577776, 639537UNII R85M2X0D68UPC 0333342117106, 0333342116109, 0333342114105, 0333342114075, 0333342116079, 0333342117076, 0333342115072, 0333342114129, 0333342115102, 0333342117120, 0333342115126, 0333342116123
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

N433342011607 followed by a unit qualifier and the quantity

Package 33342-0116-07. 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 Dec 28, 2022. 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 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 non-fatal car…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203813

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

FDA NDC Directory listings under ANDA 203813
Product	Strength	Form · route	Labeler	Product NDC
Candesartan	Candesartan cilexetil 16 mg/1	TabletOral	NorthStar RxLLC	72603-720
Candesartan	Candesartan cilexetil 32 mg/1	TabletOral	NorthStar RxLLC	72603-721
Candesartan	Candesartan cilexetil 4 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-114
Candesartan	Candesartan cilexetil 8 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-115
Candesartan	Candesartan cilexetil 32 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-117
Candesartan	Candesartan cilexetil 16 mg/1	TabletOral	Bryant Ranch Prepack	71335-3032