What is NDC 43353-085?

43353-085 is the product NDC for valproic acid, Valproic acid 250 mg/1 capsule, 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 43353-085 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43353-085Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43353-0085Add 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
43353-085-53	4335300855343353008553	60 CAPSULE in 1 BOTTLE (43353-085-53)Marketed from Jul 20, 2015
43353-085-60	4335300856043353008560	90 CAPSULE in 1 BOTTLE (43353-085-60)Marketed from Jul 20, 2015
43353-085-70	4335300857043353008570	120 CAPSULE in 1 BOTTLE (43353-085-70)Marketed from Dec 16, 2015
43353-085-80	4335300858043353008580	180 CAPSULE in 1 BOTTLE (43353-085-80)Marketed from Dec 15, 2015
43353-085-90	4335300859043353008590	240 CAPSULE in 1 BOTTLE (43353-085-90)Marketed from May 23, 2016
43353-085-94	4335300859443353008594	360 CAPSULE in 1 BOTTLE (43353-085-94)Marketed from Oct 28, 2015

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
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 073229
Marketing start: Oct 29, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 43353-085_a83d04b7-84f7-4967-9721-a82a0fe8d83eSPL ID a83d04b7-84f7-4967-9721-a82a0fe8d83eSPL set ID 3904177b-8a26-4356-9080-d2a2e3f468afRxCUI 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

N443353008553 followed by a unit qualifier and the quantity

Package 43353-0085-53. 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, USP 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 s…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43353-085

What is NDC 43353-085?: 43353-085 is the product NDC for valproic acid, Valproic acid 250 mg/1 capsule, 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 073229

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

FDA NDC Directory listings under ANDA 073229
Product	Strength	Form · route	Labeler	Product NDC
Valproicvalproic acid	Valproic acid 250 mg/1	Capsule, Liquid filledOral	Actavis Pharma, Inc.	0591-4012
Valproicvalproic acid	Valproic acid 250 mg/1	Capsule, Liquid filledOral	Aphena Pharma Solutions - Tennessee, LLC	71610-906
valproic acid	Valproic acid 250 mg/1	CapsuleOral	Upsher-Smith Laboratories, LLC	0832-0310
Valproic Acid	Valproic acid 250 mg/1	CapsuleOral	Direct_Rx	72189-010