What is NDC 43353-279?

43353-279 is the product NDC for Valproic Acid, Valproic acid 250 mg/1 capsule, liquid filled, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 6 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Valproic Acid?

27 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Valproic Acid NDC 43353-279 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43353-279Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43353-0279Add 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
43353-279-53	4335302795343353027953	60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-53)Marketed from Feb 11, 2017
43353-279-60	4335302796043353027960	90 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-60)Marketed from Feb 11, 2017
43353-279-70	4335302797043353027970	120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-70)Marketed from Feb 16, 2017
43353-279-80	4335302798043353027980	180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-80)Marketed from Feb 11, 2017
43353-279-90	4335302799043353027990	240 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-90)Marketed from Apr 25, 2017
43353-279-94	4335302799443353027994	360 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-94)Marketed from Mar 7, 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): Valproic Acid
Generic name (nonproprietary): valproic acid
Active ingredients: Valproic acid — 250 mg/1
Dosage form: Capsule, Liquid filled
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 43353
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 073484
Marketing start: Jul 15, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 43353-279_1f5efbea-ccd0-4213-9324-769b0077144fSPL ID 1f5efbea-ccd0-4213-9324-769b0077144fSPL set ID 3798f957-8b32-4ac0-8fd1-80283414c255RxCUI 1099681UNII 614OI1Z5WI
Pharmacologic class: Anti-epileptic Agent; Mood Stabilizer

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

N443353027953 followed by a unit qualifier and the quantity

Package 43353-0279-53. 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 Oct 17, 2017. This label includes a boxed warning.

Indications (excerpt from the label)

Valproic Acid Capsules are an anti-epileptic drug indicated for: Monotherapy and adjunctive therapy of complex partial seizures; sole and adjunctive therapy of simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1 ) 1.1 Epilepsy Valproic Acid Capsules are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Valproic Acid Capsules are indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizur…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43353-279

What is NDC 43353-279?: 43353-279 is the product NDC for Valproic Acid, Valproic acid 250 mg/1 capsule, liquid filled, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Valproic Acid.
What is the active ingredient?: Valproic acid.
Who is the labeler?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Valproic Acid?: 27 other product NDCs are listed under this name. See all Valproic 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 Valproic Acid NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	American Health Packaging	60687-942	60687-0942-1760687-0942-77
Valproic Acid	Valproic acid 500 mg/10mL	SolutionOral	American Health Packaging	60687-953	60687-0953-56
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	Major Pharmaceuticals	0904-7620	00904-7620-7000904-7620-94
Valproic Acid	Valproic acid 500 mg/10mL	SolutionOral	Major Pharmaceuticals	0904-7621	00904-7621-72
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	REMEDYREPACK INC.	70518-4298	70518-4298-0070518-4298-0270518-4298-04
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	NorthStar Rx LLC	72603-253	72603-0253-01
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	QUAGEN PHARMACEUTICALS LLC	70752-202	70752-0202-12
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	ANI Pharmaceuticals, Inc.	62559-266	62559-0266-16
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	Kesin Pharma Corporation	81033-266	81033-0266-5081033-0266-52
Valproic Acid	Valproic acid 250 mg/5mL	SolutionOral	REMEDYREPACK INC.	70518-3805	70518-3805-0070518-3805-02

All 28 Valproic Acid NDCs

Other NDCs under ANDA 073484

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

FDA NDC Directory listings under ANDA 073484
Product	Strength	Form · route	Labeler	Product NDC
Valproic Acid	Valproic acid 250 mg/1	Capsule, Liquid filledOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8205
Valproic Acid	Valproic acid 250 mg/1	Capsule, Liquid filledOral	ATLANTIC BIOLOGICALS CORP.	17856-0152
Valproic Acid	Valproic acid 250 mg/1	Capsule, Liquid filledOral	Bryant Ranch Prepack	63629-2454
Valproic Acid	Valproic acid 250 mg/1	Capsule, Liquid filledOral	Bionpharma Inc.	69452-150
Valproic Acid	Valproic acid 250 mg/1	Capsule, Liquid filledOral	REMEDYREPACK INC.	70518-0079