Prescription drug · NDA
Arestin (Minocycline hydrochloride) NDC 65976-100
Minocycline hydrochloride 1 mg/1 · Powder · Oral · OraPharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65976-100-01 | 65976010001 | 1 POWDER in 1 POUCH (65976-100-01)Marketed from Mar 21, 2011 | |
| 65976-100-12 | 65976010012 | 1 POUCH in 1 BOX (65976-100-12) / 1 TRAY in 1 POUCH / 12 POWDER in 1 TRAYMarketed from Mar 21, 2011 | |
| 65976-100-24 | 65976010024 | 2 POUCH in 1 BOX (65976-100-24) / 1 TRAY in 1 POUCH / 12 POWDER in 1 TRAYMarketed from Mar 21, 2011 |
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)
- Arestin
- Generic name (nonproprietary)
- minocycline hydrochloride
- Active ingredients
- Minocycline hydrochloride — 1 mg/1
- Dosage form
- Powder
- Route
- Oral
- Labeler
- OraPharma, Inc.NDC labeler code 65976
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050781
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Prothrombin Activity (Physiologic effect)Tetracyclines (Chemical structure)
- Identifiers
- Product ID 65976-100_668385ee-9443-4d20-b0ea-655c2526ca96SPL ID 668385ee-9443-4d20-b0ea-655c2526ca96SPL set ID 8515df41-1936-4f3b-86ba-d2bb2a8441fbRxCUI 351121, 351974UNII 0020414E5U
- Pharmacologic class
- Tetracycline-class Drug
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N465976010001followed by a unit qualifier and the quantityPackage 65976-0100-01. 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 USE ARESTIN is indicated as an adjunct to scaling and root planing procedures for reduction of pocket depth in patients with adult periodontitis. ARESTIN may be used as part of a periodontal maintenance program which includes good oral hygiene and scaling and root planing.
Excerpt only. Read the full label for complete information.
About NDC 65976-100
- What is NDC 65976-100?
- 65976-100 is the product NDC for Arestin (minocycline hydrochloride), Minocycline hydrochloride 1 mg/1 powder, listed with the FDA by OraPharma, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Arestin (Minocycline Hydrochloride).
- What is the active ingredient?
- Minocycline hydrochloride.
- Who is the labeler?
- OraPharma, Inc., NDC labeler code 65976. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Arestin?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.