Prescription drug · ANDA
Pregabalin NDC 71335-1505
Pregabalin 300 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1505-1 | 7133515050171335150501 | 60 CAPSULE in 1 BOTTLE (71335-1505-1)Marketed from Feb 19, 2020 | |
| 71335-1505-2 | 7133515050271335150502 | 90 CAPSULE in 1 BOTTLE (71335-1505-2)Marketed from Sep 20, 2022 | |
| 71335-1505-3 | 7133515050371335150503 | 30 CAPSULE in 1 BOTTLE (71335-1505-3)Marketed from Sep 20, 2022 |
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)
- Pregabalin
- Generic name (nonproprietary)
- pregabalin
- Active ingredients
- Pregabalin — 300 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210432
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 71335-1505_ef869518-e222-4dab-a77b-820fec1ce911SPL ID ef869518-e222-4dab-a77b-820fec1ce911SPL set ID 15b5e3d0-2bad-4363-99cb-e15819c41fdaRxCUI 483444UNII 55JG375S6M
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
N471335150501followed by a unit qualifier and the quantityPackage 71335-1505-01. 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 .
Indications (excerpt from the label)
Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury Pregabalin capsules are indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1 ) Postherpetic neuralgia (PHN) (1) Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older ( 1) Fibromyalgia ( 1) Neuropathic pain associated with spinal cord injury (1 )
Excerpt only. Read the full label for complete information.
About NDC 71335-1505
- What is NDC 71335-1505?
- 71335-1505 is the product NDC for Pregabalin, Pregabalin 300 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pregabalin.
- What is the active ingredient?
- Pregabalin.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pregabalin?
- 503 other product NDCs are listed under this name. See all Pregabalin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pregabalin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4749 | 70518-4749-00 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4743 | 70518-4743-00 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-439 | 29300-0439-19 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-440 | 29300-0440-19 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-441 | 29300-0441-19 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-442 | 29300-0442-19 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-443 | 29300-0443-19 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-444 | 29300-0444-19 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-445 | 29300-0445-19 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-446 | 29300-0446-19 |
Other NDCs under ANDA 210432
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 |
|---|---|---|---|---|
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-6991 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-6992 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7000 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7001 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7002 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7003 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7004 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7005 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6793 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-4308 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-8097 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-8098 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Quality Care Products, LLC | 55700-773 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Quality Care Products, LLC | 55700-774 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Quality Care Products, LLC | 55700-775 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | American Health Packaging | 60687-473 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | American Health Packaging | 60687-484 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | American Health Packaging | 60687-495 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | American Health Packaging | 60687-506 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | American Health Packaging | 60687-517 |
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