NDC codes

FDA NDC Directory
Product NDC (as listed)65976-100Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65976-0100Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
65976-100-01659760100011 POWDER in 1 POUCH (65976-100-01)Marketed from Mar 21, 2011
65976-100-12659760100121 POUCH in 1 BOX (65976-100-12) / 1 TRAY in 1 POUCH / 12 POWDER in 1 TRAYMarketed from Mar 21, 2011
65976-100-24659760100242 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

N465976010001 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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