Prescription drug · ANDA
acyclovir NDC 13668-515
Acyclovir 50 mg/g · Ointment · Topical · Torrent Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13668-515-01 | 1366805150113668051501 | 15 g in 1 TUBE (13668-515-01)Marketed from Jan 11, 2019 | |
| 13668-515-02 | 1366805150213668051502 | 30 g in 1 TUBE (13668-515-02)Marketed from Jan 11, 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 — 50 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- Torrent Pharmaceuticals LimitedNDC labeler code 13668
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209971
- Marketing start
- Listing expires
- Other FDA classes
- DNA Polymerase Inhibitors (Mechanism)Nucleoside Analog (EXT)
- Identifiers
- Product ID 13668-515_82d1c086-8b8a-419e-b5e7-2aa0a1cbf1b9SPL ID 82d1c086-8b8a-419e-b5e7-2aa0a1cbf1b9SPL set ID 1c510390-fb00-4271-967d-0883a9d5e1fdRxCUI 197312UNII X4HES1O11FUPC 0313668515015, 0313668515022
- 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
N413668051501followed by a unit qualifier and the quantityPackage 13668-0515-01. 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)
INDICATIONS AND USAGE: Acyclovir ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.
Excerpt only. Read the full label for complete information.
About NDC 13668-515
- What is NDC 13668-515?
- 13668-515 is the product NDC for acyclovir, Acyclovir 50 mg/g ointment, listed with the FDA by Torrent Pharmaceuticals Limited. It has 2 package NDCs, 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?
- Torrent Pharmaceuticals Limited, NDC labeler code 13668. 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 ANDA 209971
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.