What is NDC 46708-245?

46708-245 is the product NDC for Fenofibric Acid, Fenofibric acid 135 mg/1 capsule, delayed release, 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 Fenofibric Acid?

13 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fenofibric Acid NDC 46708-245 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-245Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0245Add 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
46708-245-30	4670802453046708024530	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-245-30)Marketed from May 18, 2017
46708-245-90	4670802459046708024590	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-245-90)Marketed from May 18, 2017
46708-245-91	4670802459146708024591	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-245-91)Marketed from May 18, 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): Fenofibric Acid
Generic name (nonproprietary): fenofibric acid
Active ingredients: Fenofibric acid — 135 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208705
Marketing start: May 18, 2017
Listing expires: Dec 31, 2027
Identifiers: Product ID 46708-245_4f5277a1-2983-4cf9-b589-714d5fc586c0SPL ID 4f5277a1-2983-4cf9-b589-714d5fc586c0SPL set ID c880d43a-fa8c-4f7a-a488-419bae7cc311RxCUI 828373, 828379UNII BGF9MN2HU1UPC 0346708244309, 0346708245306
Pharmacologic class: Peroxisome Proliferator Receptor alpha Agonist

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

N446708024530 followed by a unit qualifier and the quantity

Package 46708-0245-30. 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 30, 2023.

Indications (excerpt from the label)

Fenofibric acid delayed-release capsules are a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to: · Reduce TG in patients with severe hypertriglyceridemia (1.1). · Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDLC in patients with primary hypercholesterolemia or mixed dyslipidemia (1.2). Limitations of Use: Fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed-release capsules did not reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1) 1.1 Treatment of Severe Hypertriglyceridemia Fenofibric acid delayed-release capsules are indicated as adjunctive therap…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-245

What is NDC 46708-245?: 46708-245 is the product NDC for Fenofibric Acid, Fenofibric acid 135 mg/1 capsule, delayed release, 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?: Fenofibric Acid.
What is the active ingredient?: Fenofibric acid.
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 Fenofibric Acid?: 13 other product NDCs are listed under this name. See all Fenofibric Acid 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 Fenofibric Acid NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fenofibric Acid	Fenofibric acid 45 mg/1	Capsule, Delayed releaseOral	Amneal Pharmaceuticals of New York LLC	0115-1324	00115-1324-10
Fenofibric Acid	Fenofibric acid 135 mg/1	Capsule, Delayed releaseOral	Amneal Pharmaceuticals of New York LLC	0115-1325	00115-1325-10
Fenofibric acid	Choline fenofibrate 45 mg/1	Capsule, Delayed releaseOral	Macleods Pharmaceuticals Limited	33342-294	33342-0294-1033342-0294-12
Fenofibric acid	Choline fenofibrate 135 mg/1	Capsule, Delayed releaseOral	Macleods Pharmaceuticals Limited	33342-295	33342-0295-1033342-0295-56
Fenofibric Acid	Fenofibric acid 45 mg/1	Capsule, Delayed releaseOral	Aurobindo Pharma Limited	59651-216	59651-0216-90
Fenofibric Acid	Fenofibric acid 135 mg/1	Capsule, Delayed releaseOral	Aurobindo Pharma Limited	59651-217	59651-0217-90
Fenofibric Acid	Fenofibric acid 45 mg/1	Capsule, Delayed releaseOral	Leading Pharma, LLC	69315-281	69315-0281-09
Fenofibric Acid	Fenofibric acid 135 mg/1	Capsule, Delayed releaseOral	Leading Pharma, LLC	69315-282	69315-0282-09
Fenofibric Acid	Fenofibric acid 45 mg/1	Capsule, Delayed releaseOral	Alembic Pharmaceuticals Limited	46708-244	46708-0244-3046708-0244-9046708-0244-91
Fenofibric Acid	Fenofibric acid 45 mg/1	Capsule, Delayed releaseOral	Alembic Pharmaceuticals Inc.	62332-244	62332-0244-3062332-0244-9062332-0244-91

All 14 Fenofibric Acid NDCs

Other NDCs under ANDA 208705

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

FDA NDC Directory listings under ANDA 208705
Product	Strength	Form · route	Labeler	Product NDC
Fenofibric Acid	Fenofibric acid 45 mg/1	Capsule, Delayed releaseOral	Alembic Pharmaceuticals Limited	46708-244
Fenofibric Acid	Fenofibric acid 45 mg/1	Capsule, Delayed releaseOral	Alembic Pharmaceuticals Inc.	62332-244
Fenofibric Acid	Fenofibric acid 135 mg/1	Capsule, Delayed releaseOral	Alembic Pharmaceuticals Inc.	62332-245