Over-the-counter drug · ANDA
Docosanol NDC 69452-550
Docosanol 100 mg/g · Cream · Topical · BIONPHARMA INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-550-02 | 6945205500269452055002 | 2 TUBE in 1 CARTON (69452-550-02) / 2 g in 1 TUBEMarketed from Oct 10, 2026 | |
| 69452-550-61 | 6945205506169452055061 | 1 BOTTLE, PUMP in 1 CARTON (69452-550-61) / 2 g in 1 BOTTLE, PUMPMarketed from Oct 10, 2026 |
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
- BIONPHARMA INC.NDC labeler code 69452
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220017
- Marketing start
- Listing expires
- Identifiers
- Product ID 69452-550_5dc20ccc-e1b2-346f-e063-6294a90a7592SPL ID 5dc20ccc-e1b2-346f-e063-6294a90a7592
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
N469452055002followed by a unit qualifier and the quantityPackage 69452-0550-02. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 69452-550
- What is NDC 69452-550?
- 69452-550 is the product NDC for Docosanol, Docosanol 100 mg/g cream, listed with the FDA by BIONPHARMA INC.. 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?
- BIONPHARMA INC., NDC labeler code 69452. 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 | 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 | Alembic Pharmaceuticals Limited | 46708-682 | 46708-0682-0146708-0682-03 |
| 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 220017
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 | KLM Laboratories Private Limited | 84725-001 |