Prescription drug · NDA
Gralise (Gabapentin) NDC 52427-850
Gabapentin 750 mg/1 · Tablet, Film coated · Oral · Almatica Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52427-850-60 | 5242708506052427085060 | 60 TABLET, FILM COATED in 1 BOTTLE (52427-850-60)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 — 750 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Almatica Pharma LLCNDC labeler code 52427
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022544
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 52427-850_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
N452427085060followed by a unit qualifier and the quantityPackage 52427-0850-60. 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 .
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.
About NDC 52427-850
- What is NDC 52427-850?
- 52427-850 is the product NDC for Gralise (gabapentin), Gabapentin 750 mg/1 tablet, film coated, listed with the FDA by Almatica Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gralise (Gabapentin).
- What is the active ingredient?
- Gabapentin.
- Who is the labeler?
- Almatica Pharma LLC, NDC labeler code 52427. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gralise?
- 4 other product NDCs are listed under this name. See all Gralise NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gralise products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gralisegabapentin | Gabapentin 450 mg/1 | Tablet, Film coatedOral | Almatica Pharma LLC | 52427-804 | 52427-0804-60 |
| Gralisegabapentin | Gabapentin 900 mg/1 | Tablet, Film coatedOral | Almatica Pharma LLC | 52427-890 | 52427-0890-60 |
| Gralisegabapentin | Gabapentin 300 mg/1 | Tablet, Film coatedOral | Almatica Pharma LLC | 52427-803 | 52427-0803-90 |
| Gralisegabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | Almatica Pharma LLC | 52427-806 | 52427-0806-90 |
Other NDCs under NDA 022544
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Gralisegabapentin | Gabapentin 300 mg/1 | Tablet, Film coatedOral | Almatica Pharma LLC | 52427-803 |
| Gralisegabapentin | Gabapentin 450 mg/1 | Tablet, Film coatedOral | Almatica Pharma LLC | 52427-804 |
| Gralisegabapentin | Gabapentin 600 mg/1 | Tablet, Film coatedOral | Almatica Pharma LLC | 52427-806 |
| Gralisegabapentin | Gabapentin 900 mg/1 | Tablet, Film coatedOral | Almatica Pharma LLC | 52427-890 |