Prescription drug · ANDA
Acyclovir NDC 54348-624
Acyclovir 800 mg/1 · Tablet · Oral · PharmPak, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54348-624-10 | 54348062410 | 1 BOTTLE in 1 BOX (54348-624-10) / 10 TABLET in 1 BOTTLEMarketed from Jul 9, 2019 |
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)
- Acyclovir
- Generic name (nonproprietary)
- acyclovir
- Active ingredients
- Acyclovir — 800 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PharmPak, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203834
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 54348-624_ea935f93-6c2c-2e8a-e053-2995a90a2ce0SPL ID ea935f93-6c2c-2e8a-e053-2995a90a2ce0SPL set ID d824fc07-9f03-4cb2-9bf8-ff7cc2955255RxCUI 197313UNII X4HES1O11F
- Pharmacologic class
- Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor; Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor; Herpesvirus Nucleoside Analog DNA Polymerase 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
N454348062410followed by a unit qualifier and the quantityPackage 54348-0624-10. 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 & USAGE Herpes Zoster Infections: Acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203834
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 |
|---|---|---|---|---|
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-1841 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-778 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0323 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-777 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | Proficient Rx LP | 63187-253 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2117 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3222 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-928 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-778 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0270 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | PharmPak, Inc. | 54348-627 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-679 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | A-S Medication Solutions | 50090-6844 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4799 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7575 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2455 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2518 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-589 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-300 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7507 |
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