Prescription drug · ANDA
Gabapentin NDC 71610-088
Gabapentin 300 mg/1 · Capsule · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-088-53 | 71610008853 | 60 CAPSULE in 1 BOTTLE (71610-088-53)Marketed from Jun 21, 2018 | |
| 71610-088-60 | 71610008860 | 90 CAPSULE in 1 BOTTLE (71610-088-60)Marketed from Jun 21, 2018 | |
| 71610-088-80 | 71610008880 | 180 CAPSULE in 1 BOTTLE (71610-088-80)Marketed from Jun 21, 2018 | |
| 71610-088-92 | 71610008892 | 270 CAPSULE in 1 BOTTLE (71610-088-92)Marketed from Jun 21, 2018 | |
| 71610-088-94 | 71610008894 | 360 CAPSULE in 1 BOTTLE (71610-088-94)Marketed from Jun 21, 2018 |
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)
- Gabapentin
- Generic name (nonproprietary)
- gabapentin
- Active ingredients
- Gabapentin — 300 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090007
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 71610-088_0515dc32-e7fc-4208-9677-ec9dfad018f1SPL ID 0515dc32-e7fc-4208-9677-ec9dfad018f1SPL set ID 9d1b9121-c25a-4d28-91c5-5fc72f1167f4RxCUI 310431UNII 6CW7F3G59X
- Pharmacologic class
- Anti-epileptic Agent
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
N471610008853followed by a unit qualifier and the quantityPackage 71610-0088-53. 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 .
Other NDCs under ANDA 090007
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 |
|---|---|---|---|---|
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bi-Coastal Pharma International LLC | 42582-115 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Bi-Coastal Pharma International LLC | 42582-114 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | Bi-Coastal Pharma International LLC | 42582-116 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-7024 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | DIRECT RX | 72189-109 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | DIRECT RX | 72189-113 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0993 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1490 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | MARKSANS PHARMA LIMITED | 25000-103 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | MARKSANS PHARMA LIMITED | 25000-104 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | MARKSANS PHARMA LIMITED | 25000-105 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4784 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-123 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | DIRECT RX | 61919-640 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0079 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1991 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2005 |
| Gabapentin | Gabapentin 100 mg/1 | CapsuleOral | TIME CAP LABORATORIES, INC | 49483-605 |
| Gabapentin | Gabapentin 300 mg/1 | CapsuleOral | TIME CAP LABORATORIES, INC | 49483-606 |
| Gabapentin | Gabapentin 400 mg/1 | CapsuleOral | TIME CAP LABORATORIES, INC | 49483-607 |
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