Over-the-counter drug · ANDA
Abreva (Docosanol) NDC 0135-0300
Docosanol 100 mg/g · Cream · Topical · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0135-0300-01 | 0013503000100135030001 | 1 TUBE in 1 PACKAGE (0135-0300-01) / 2 g in 1 TUBEMarketed from Mar 25, 2022 | |
| 0135-0300-02 | 0013503000200135030002 | 2 TUBE in 1 PACKAGE (0135-0300-02) / 2 g in 1 TUBEMarketed from Apr 25, 2022 |
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)
- Abreva
- Generic name (nonproprietary)
- docosanol
- Active ingredients
- Docosanol — 100 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Haleon US Holdings LLCNDC labeler code 0135
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208754
- Marketing start
- Listing expires
- Identifiers
- Product ID 0135-0300_1b529b4c-e36d-5070-e063-6294a90ac5c8SPL ID 1b529b4c-e36d-5070-e063-6294a90ac5c8SPL set ID bf02c8c5-af60-41f1-a202-38a97491a720RxCUI 797534, 855205UNII 9G1OE216XY
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
N400135030001followed by a unit qualifier and the quantityPackage 00135-0300-01. 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 0135-0300
- What is NDC 0135-0300?
- 0135-0300 is the product NDC for Abreva (docosanol), Docosanol 100 mg/g cream, listed with the FDA by Haleon US Holdings LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Abreva (Docosanol).
- What is the active ingredient?
- Docosanol.
- Who is the labeler?
- Haleon US Holdings LLC, NDC labeler code 0135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Abreva?
- 1 other product NDC are listed under this name. See all Abreva NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Abreva products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Abrevadocosanol | Docosanol 100 mg/g | CreamTopical | Haleon US Holdings LLC | 0135-0200 | 00135-0200-0100135-0200-0300135-0200-05+1 more |
Other NDCs under ANDA 208754
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 |
|---|---|---|---|---|
| Cold Sore Fever Blisterdocosanol | Docosanol 100 mg/g | CreamTopical | H E B | 37808-223 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Walgreens | 0363-8877 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Walgreens | 0363-9220 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Walgreens | 0363-9222 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | TARGET Corporation | 11673-846 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Safeway, Inc. | 21130-823 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | The Kroger Co. | 30142-981 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-963 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | P & L Development, LLC | 59726-877 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Chain Drug Consortium, LLC | 68016-344 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Topco Associates | 76162-900 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | Meijer Distribution Inc. | 79481-9220 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | WALMART INC. (see also Equate) | 79903-435 |
| Cold Sore Fever Blister Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | FSA Store Inc. (Caring Mills) | 81522-923 |
| Cold Sore Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | H E B | 37808-229 |
| Cold Sore Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | P & L Development, LLC | 59726-924 |
| Cold Sore Treatmentdocosanol | Docosanol 100 mg/g | CreamTopical | FSA Store Inc. (Caring Mills) | 81522-922 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | United Natural Foods, Inc. dba UNFI | 41163-724 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | MEIJER, INC. | 41250-867 |
| Docosanol | Docosanol 100 mg/g | CreamTopical | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-259 |
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