Horizant (gabapentin enacarbil) NDC 53451-0101

NDC codes

FDA NDC Directory

Product NDC (as listed)53451-0101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53451-0101Add 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
53451-0101-1	53451010101	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0101-1)Marketed from May 1, 2013
53451-0101-9	53451010109	5 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0101-9)Marketed from May 1, 2013

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Horizant
Generic name (nonproprietary): gabapentin enacarbil
Active ingredients: Gabapentin enacarbil — 600 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022399
Marketing start: May 1, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 53451-0101_33da187f-72d1-daa5-e063-6394a90a66b1SPL ID 33da187f-72d1-daa5-e063-6394a90a66b1SPL set ID 4c486fc7-c8c4-4c6c-b30c-366dabaeaaddRxCUI 1101338, 1101339, 1482820, 1482821UNII 75OCL1SPBQ

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

N453451010101 followed by a unit qualifier and the quantity

Package 53451-0101-01. 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 Apr 28, 2025.

Indications (excerpt from the label)

HORIZANT is indicated for: treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults. ( 1.1 ) management of postherpetic neuralgia (PHN) in adults. ( 1.2 ) 1.1 Treatment of Restless Legs Syndrome HORIZANT ® is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults. HORIZANT is not recommended for patients who are required to sleep during the daytime and remain awake at night. 1.2 Management of Postherpetic Neuralgia HORIZANT is indicated for the management of postherpetic neuralgia (PHN) in adults.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022399

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

FDA NDC Directory listings under NDA 022399
Product	Strength	Form · route	Labeler	Product NDC
Horizantgabapentin enacarbil	Gabapentin enacarbil 300 mg/1	Tablet, Extended releaseOral	Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)	53451-0103