Prescription drug · ANDA
Amantadine Hydrochloride NDC 0904-7042
Amantadine hydrochloride 100 mg/1 · Capsule · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7042-06 | 00904704206 | 50 BLISTER PACK in 1 CARTON (0904-7042-06) / 1 CAPSULE in 1 BLISTER PACKMarketed from Jun 12, 2017 | |
| 0904-7042-40 | 00904704240 | 500 CAPSULE in 1 BOTTLE (0904-7042-40)Marketed from Jun 12, 2017 | |
| 0904-7042-59 | 00904704259 | 100 CAPSULE in 1 BOTTLE (0904-7042-59)Marketed from Jun 12, 2017 | |
| 0904-7042-61 | 00904704261 | 100 BLISTER PACK in 1 CARTON (0904-7042-61) / 1 CAPSULE in 1 BLISTER PACKMarketed from Jun 12, 2017 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Amantadine Hydrochloride
- Generic name (nonproprietary)
- amantadine hydrochloride
- Active ingredients
- Amantadine hydrochloride — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209171
- Marketing start
- Listing expires
- Other FDA classes
- M2 Protein Inhibitors (Mechanism)
- Identifiers
- Product ID 0904-7042_e997ef48-cfa3-4aa8-bbea-be54c4c00f64SPL ID e997ef48-cfa3-4aa8-bbea-be54c4c00f64SPL set ID b2f7da34-ad78-4db3-9af1-bdd341e09f16RxCUI 849389UNII M6Q1EO9TD0
- Pharmacologic class
- Influenza A M2 Protein Inhibitor
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
N400904704206followed by a unit qualifier and the quantityPackage 00904-7042-06. 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)
INDICATIONS AND USAGE Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride capsules are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected whe…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209171
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 |
|---|---|---|---|---|
| Amantadine Hydrochloride | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2408 |
| Amantadine Hydrochloride | Amantadine hydrochloride 100 mg/1 | CapsuleOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8263 |
| Amantadine Hydrochloride | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-362 |
| Amantadine Hydrochloride | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2664 |
| Amantadine Hydrochloride | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2919 |
| Amantadine Hydrochloride | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2959 |
| Amantadine Hydrochloride | Amantadine hydrochloride 100 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-609 |