Over-the-counter drug · ANDA
Docosanol NDC 46708-682
Docosanol 100 mg/g · Cream · Topical · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-682-01 | 4670806820146708068201 | 1 TUBE in 1 PACKAGE (46708-682-01) / 2 g in 1 TUBEMarketed from May 8, 2025 | |
| 46708-682-03 | 4670806820346708068203 | 1 BOTTLE, PUMP in 1 PACKAGE (46708-682-03) / 2 g in 1 BOTTLE, PUMPMarketed from May 8, 2025 |
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)
- Docosanol
- Generic name (nonproprietary)
- docosanol
- Active ingredients
- Docosanol — 100 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215839
- Marketing start
- Listing expires
- Identifiers
- Product ID 46708-682_91169ef2-b68b-4da3-b698-2bfc01f441cfSPL ID 91169ef2-b68b-4da3-b698-2bfc01f441cfSPL set ID a87a077d-9b0e-490d-b4ac-26c7045828dbRxCUI 797534UNII 9G1OE216XYUPC 0346708682019
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
N446708068201followed by a unit qualifier and the quantityPackage 46708-0682-01. 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)
Uses treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: • tingling, pain, burning, and/or itching
Excerpt only. Read the full label for complete information.
About NDC 46708-682
- What is NDC 46708-682?
- 46708-682 is the product NDC for Docosanol, Docosanol 100 mg/g cream, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Docosanol.
- What is the active ingredient?
- Docosanol.
- Who is the labeler?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Docosanol?
- 35 other product NDCs are listed under this name. See all Docosanol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Docosanol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Docosanol | Docosanol 100 mg/g | CreamTopical | BIONPHARMA INC. | 69452-550 | 69452-0550-0269452-0550-61 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | Dr.Reddys' Laboratories Inc | 43598-946 | 43598-0946-0243598-0946-1343598-0946-22 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | Dr.Reddys' Laboratories Inc | 43598-044 | 43598-0044-0243598-0044-33 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | KLM Laboratories Private Limited | 84725-001 | 84725-0001-0184725-0001-0284725-0001-09 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | Leader/ Cardinal Health 110, Inc. | 70000-0743 | 70000-0743-01 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | WALMART INC. (see also Equate) | 79903-402 | 79903-0402-1079903-0402-20 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | Publix Super Markets Inc. | 41415-660 | 41415-0660-03 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | H2-Pharma, LLC | 61269-881 | 61269-0881-35 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | YYBA Corp | 73581-004 | 73581-0004-0273581-0004-0373581-0004-10+1 more |
| Docosanol | Docosanol 100 mg/g | CreamTopical | Amerisource Bergen | 46122-800 | 46122-0800-36 |
Other NDCs under ANDA 215839
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 |
|---|---|---|---|---|
| Docosanol | Docosanol 100 mg/g | CreamTopical | Rugby Laboratories | 0536-1427 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | Cosette Pharmaceuticals, Inc. | 0713-0353 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | CVS Pharmacy, Inc. | 51316-763 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | Alembic Pharmaceuticals Inc. | 62332-682 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | Leader/ Cardinal Health 110, Inc. | 70000-0672 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | Leader/ Cardinal Health 110, Inc. | 70000-0743 |