NDC codes

FDA NDC Directory
Product NDC (as listed)55259-1191Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55259-1191Add 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
55259-1191-155259119101120 TABLET in 1 BOTTLE (55259-1191-1)Marketed from Sep 7, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Prevent Restoration
Generic name (nonproprietary)
oyster shell
Active ingredients
Ostrea edulis shell — .67 mg/1
Dosage form
Tablet
Route
Oral
Labeler
APEXEL CO., LTD.NDC labeler code 55259
Product type
Over-the-counter drug
Marketing category
Unapproved drug (other)
Marketing start
Listing expires
Identifiers
Product ID 55259-1191_11df6e71-201d-327a-e063-6294a90aec6aSPL ID 11df6e71-201d-327a-e063-6294a90aec6aSPL set ID 11df6e80-3dea-ca38-e063-6394a90a31a9UNII 49OY13BE7Z

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

N455259119101 followed by a unit qualifier and the quantity

Package 55259-1191-01. 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)

INDICATION & USAGE SECTION take two capsules once, two times a day

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55259-1191

What is NDC 55259-1191?
55259-1191 is the product NDC for Prevent Restoration (oyster shell), Ostrea edulis shell .67 mg/1 tablet, listed with the FDA by APEXEL CO., LTD.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Prevent Restoration (Oyster shell).
What is the active ingredient?
Ostrea edulis shell.
Who is the labeler?
APEXEL CO., LTD., NDC labeler code 55259. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Prevent Restoration?
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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