What is NDC 13548-070?

13548-070 is the product NDC for Atralin (tretinoin), Tretinoin .05 g/100g gel, listed with the FDA by Bausch Health US, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Bausch Health US, LLC, NDC labeler code 13548. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Atralin?

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.

Atralin NDC 13548-070 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)13548-070Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13548-0070Add 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
13548-070-45	1354800704513548007045	1 TUBE in 1 PACKAGE (13548-070-45) / 45 g in 1 TUBEMarketed from Jul 26, 2007

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): Atralin
Generic name (nonproprietary): tretinoin
Active ingredients: Tretinoin — .05 g/100g
Dosage form: Gel
Route: Topical
Labeler: Bausch Health US, LLCNDC labeler code 13548
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022070
Marketing start: Jul 26, 2007
Listing expires: Dec 31, 2027
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 13548-070_77e095d6-f941-44ef-ad04-08d607843d65SPL ID 77e095d6-f941-44ef-ad04-08d607843d65SPL set ID b6b45969-a64a-4ce3-b3b6-157d2568a301RxCUI 245723, 749329UNII 5688UTC01R
Pharmacologic class: Retinoid

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

N413548007045 followed by a unit qualifier and the quantity

Package 13548-0070-45. 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 Feb 1, 2024.

Indications (excerpt from the label)

Atralin Gel is indicated for topical treatment of acne vulgaris. Atralin Gel is a retinoid indicated for topical treatment of acne vulgaris. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 13548-070

What is NDC 13548-070?: 13548-070 is the product NDC for Atralin (tretinoin), Tretinoin .05 g/100g gel, listed with the FDA by Bausch Health US, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Atralin (Tretinoin).
What is the active ingredient?: Tretinoin.
Who is the labeler?: Bausch Health US, LLC, NDC labeler code 13548. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Atralin?: 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.

Other NDCs under NDA 022070

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

FDA NDC Directory listings under NDA 022070
Product	Strength	Form · route	Labeler	Product NDC
Tretinoin	Tretinoin .05 g/100g	GelTopical	Obagi Cosmeceuticals LLC	62032-413
Tretinoin	Tretinoin .05 g/100g	GelTopical	Oceanside Pharmaceuticals	68682-800

Atralin (Tretinoin) NDC 13548-070