candesartan cilexetil NDC 0378-3231

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-3231Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-3231Add 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	Copy
0378-3231-77	00378323177	90 TABLET in 1 BOTTLE, PLASTIC (0378-3231-77)Marketed from Jan 6, 2020
0378-3231-93	00378323193	30 TABLET in 1 BOTTLE, PLASTIC (0378-3231-93)Marketed from Jan 6, 2020

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 16 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078702
Marketing start: Jan 6, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 0378-3231_62815e9d-598e-4b5f-b33b-3a9659eec024SPL ID 62815e9d-598e-4b5f-b33b-3a9659eec024SPL set ID 904b357e-97bf-475e-90a5-f0449f2a428eRxCUI 153822, 153823, 577776, 639537UNII R85M2X0D68UPC 0303783232935, 0303783225937, 0303783224930
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

N400378323177 followed by a unit qualifier and the quantity

Package 00378-3231-77. 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 May 12, 2021. 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 reduce 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078702

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

FDA NDC Directory listings under ANDA 078702
Product	Strength	Form · route	Labeler	Product NDC
candesartan cilexetil	Candesartan cilexetil 32 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-3232
candesartan cilexetil	Candesartan cilexetil 4 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-3224
candesartan cilexetil	Candesartan cilexetil 8 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-3225