What is NDC 46708-343?

46708-343 is the product NDC for Candesartan Cilexetil, Candesartan cilexetil 16 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Candesartan Cilexetil?

28 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Candesartan Cilexetil NDC 46708-343

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-343Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0343Add 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
46708-343-30	4670803433046708034330	30 TABLET in 1 BOTTLE (46708-343-30)Marketed from Dec 5, 2018
46708-343-90	4670803439046708034390	90 TABLET in 1 BOTTLE (46708-343-90)Marketed from Dec 5, 2018
46708-343-91	4670803439146708034391	1000 TABLET in 1 BOTTLE (46708-343-91)Marketed from Dec 5, 2018

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 — 16 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210302
Marketing start: Dec 5, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)
Identifiers: Product ID 46708-343_aaa63206-6c7d-4996-8991-91bfdb69b821SPL ID aaa63206-6c7d-4996-8991-91bfdb69b821SPL set ID d5b43fa0-6678-4219-99f1-10d273d49bafRxCUI 153822, 153823, 577776UNII R85M2X0D68UPC 0346708341305, 0346708342302, 0346708343309
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

N446708034330 followed by a unit qualifier and the quantity

Package 46708-0343-30. 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 27, 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-343

What is NDC 46708-343?: 46708-343 is the product NDC for Candesartan Cilexetil, Candesartan cilexetil 16 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Candesartan Cilexetil.
What is the active ingredient?: Candesartan cilexetil.
Who is the labeler?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Candesartan Cilexetil?: 28 other product NDCs are listed under this name. See all Candesartan Cilexetil 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 Candesartan Cilexetil NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Candesartan cilexetil	Candesartan cilexetil 4 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-157	72578-0157-0672578-0157-16
Candesartan cilexetil	Candesartan cilexetil 8 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-158	72578-0158-0672578-0158-16
Candesartan cilexetil	Candesartan cilexetil 16 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-159	72578-0159-0672578-0159-16
Candesartan cilexetil	Candesartan cilexetil 32 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-160	72578-0160-0672578-0160-16
Candesartan cilexetil	Candesartan cilexetil 4 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-686	62559-0686-99
Candesartan cilexetil	Candesartan cilexetil 8 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-687	62559-0687-99
Candesartan cilexetil	Candesartan cilexetil 16 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-688	62559-0688-99
Candesartan cilexetil	Candesartan cilexetil 32 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	62559-689	62559-0689-98
candesartan cilexetil	Candesartan cilexetil 4 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-3224	00378-3224-7700378-3224-93
candesartan cilexetil	Candesartan cilexetil 8 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-3225	00378-3225-7700378-3225-93

All 29 Candesartan Cilexetil NDCs

Other NDCs under ANDA 210302

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

FDA NDC Directory listings under ANDA 210302
Product	Strength	Form · route	Labeler	Product NDC
Candesartan Cilexetil	Candesartan cilexetil 4 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-341
Candesartan Cilexetil	Candesartan cilexetil 8 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-342
Candesartan Cilexetil	Candesartan cilexetil 4 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-341
Candesartan Cilexetil	Candesartan cilexetil 8 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-342
Candesartan Cilexetil	Candesartan cilexetil 16 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-343
Candesartan Cilexetil	Candesartan cilexetil 16 mg/1	TabletOral	Bryant Ranch Prepack	63629-9842