Oralone (triamcinolone acetonide) NDC 51672-1335

NDC codes

FDA NDC Directory

Product NDC (as listed)51672-1335Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51672-1335Add 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 NDC	11-digit (billing)	Package	Copy
51672-1335-5	51672133505	1 TUBE in 1 CARTON (51672-1335-5) / 5 g in 1 TUBEMarketed from Oct 1, 1986
51672-1335-8	51672133508	1 TUBE in 1 CARTON (51672-1335-8) / 7.5 g in 1 TUBEMarketed from Oct 1, 1986

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): Oralone
Generic name (nonproprietary): triamcinolone acetonide
Active ingredients: Triamcinolone acetonide — 1 mg/g
Dosage form: Paste
Route: Dental
Labeler: Sun Pharmaceutical Industries, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 070730
Marketing start: Oct 1, 1986
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 51672-1335_3961db48-e5fb-c2d8-e063-6294a90ab8baSPL ID 3961db48-e5fb-c2d8-e063-6294a90ab8baSPL set ID ac1e2116-795e-4c20-974d-11fa07cf0fa7RxCUI 1085728, 1085767UNII F446C597KA
Pharmacologic class: Corticosteroid

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N451672133505 followed by a unit qualifier and the quantity

Package 51672-1335-05. 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 Jul 7, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Oralone ® (Triamcinolone Acetonide Dental Paste USP, 0.1%) is indicated for adjunctive treatment and for the temporary relief of symptoms associated with oral inflammatory lesions and ulcerative lesions resulting from trauma.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 070730

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 070730
Product	Strength	Form · route	Labeler	Product NDC
Triamcinolone Acetonide	Triamcinolone acetonide 1 mg/g	PasteDental	Preferred Pharmaceuticals Inc	68788-7814
Triamcinolone Acetonide	Triamcinolone acetonide 1 mg/g	PasteDental	Sun Pharmaceutical Industries, Inc.	51672-1267