Gralise (gabapentin) NDC 52427-804

NDC codes

FDA NDC Directory

Product NDC (as listed)52427-804Labeler and product segments. Claims need a package NDC.

Product NDC at billing width52427-0804Add 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
52427-804-60	52427080460	60 TABLET, FILM COATED in 1 BOTTLE (52427-804-60)Marketed from Dec 31, 2023

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): Gralise
Generic name (nonproprietary): gabapentin
Active ingredients: Gabapentin — 450 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Almatica Pharma LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022544
Marketing start: Dec 31, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 52427-804_6303a4c5-67f7-9ce7-c655-c87018603b54SPL ID 6303a4c5-67f7-9ce7-c655-c87018603b54SPL set ID 466273b1-c9fc-3930-c94b-aa11394d5140RxCUI 1115012, 1115013, 1806380, 1806382, 2398511, 2398512, 2634743, 2634745, 2634747, 2634749, 2634751, 2634753UNII 6CW7F3G59XUPC 0352427850608, 0352427803901, 0352427806902, 0352427890604, 0352427804601

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

N452427080460 followed by a unit qualifier and the quantity

Package 52427-0804-60. 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 Jun 30, 2026.

Indications (excerpt from the label)

GRALISE is indicated for the management of postherpetic neuralgia. GRALISE is not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration. GRALISE is indicated for the management of Postherpetic Neuralgia (PHN). Important Limitation: GRALISE is not substitutable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration (See Warnings and Precautions )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022544

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

FDA NDC Directory listings under NDA 022544
Product	Strength	Form · route	Labeler	Product NDC
Gralisegabapentin	Gabapentin 600 mg/1	Tablet, Film coatedOral	Almatica Pharma LLC	52427-806
Gralisegabapentin	Gabapentin 300 mg/1	Tablet, Film coatedOral	Almatica Pharma LLC	52427-803
Gralisegabapentin	Gabapentin 900 mg/1	Tablet, Film coatedOral	Almatica Pharma LLC	52427-890
Gralisegabapentin	Gabapentin 750 mg/1	Tablet, Film coatedOral	Almatica Pharma LLC	52427-850