Prescription drug · NDA AUTHORIZED GENERIC
Acyclovir NDC 0093-3630
Acyclovir 50 mg/g · Cream · Topical · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-3630-20 | 00093363020 | 1 TUBE in 1 CARTON (0093-3630-20) / 5 g in 1 TUBEMarketed from Aug 29, 2019 |
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)
- Acyclovir
- Generic name (nonproprietary)
- acyclovir
- Active ingredients
- Acyclovir — 50 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021478
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 0093-3630_41d48b5c-d1d0-66d0-e063-6294a90ab384SPL ID 41d48b5c-d1d0-66d0-e063-6294a90ab384SPL set ID 103f29b8-2c13-4917-a446-59d3246d48d1RxCUI 141859UNII 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400093363020followed by a unit qualifier and the quantityPackage 00093-3630-20. 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)
Acyclovir Cream is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older. Acyclovir Cream is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0093-3630
- What is NDC 0093-3630?
- 0093-3630 is the product NDC for Acyclovir, Acyclovir 50 mg/g cream, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acyclovir.
- What is the active ingredient?
- Acyclovir.
- Who is the labeler?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acyclovir?
- 193 other product NDCs are listed under this name. See all Acyclovir NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Acyclovir products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| acyclovir | Acyclovir 50 mg/g | OintmentTopical | c | 68788-4142 | 68788-4142-01 |
| Acyclovir | Acyclovir 200 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0199 | 55154-0199-00 |
| acyclovir | Acyclovir 800 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-107 | 82868-0107-3082868-0107-35 |
| Acyclovir | Acyclovir 50 mg/g | OintmentTopical | Aryeh Pharma Corp | 85957-036 | 85957-0036-0185957-0036-0285957-0036-03 |
| Acyclovir | Acyclovir 200 mg/1 | CapsuleOral | Avet Pharmaceuticals Inc. | 23155-962 | 23155-0962-0123155-0962-05 |
| Acyclovir | Acyclovir 200 mg/1 | CapsuleOral | Florida Pharmaceutical Products, LLC | 71921-146 | 71921-0146-01 |
| Acyclovir | Acyclovir 200 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7519 | 00904-7519-61 |
| Acyclovir | Acyclovir 400 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-965 | 59651-0965-0159651-0965-0559651-0965-10 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-966 | 59651-0966-0159651-0966-0559651-0966-10 |
| Acyclovir | Acyclovir 800 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4450 | 70518-4450-0070518-4450-01 |
Other NDCs under NDA 021478
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 |
|---|---|---|---|---|
| Zoviraxacyclovir | Acyclovir 50 mg/g | CreamTopical | Bausch Health US, LLC | 0187-0994 |