NDC codes

FDA NDC Directory
Product NDC (as listed)59212-601Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59212-0601Add 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
59212-601-22592120601225921206012260 g in 1 TUBE (59212-601-22)Marketed from Sep 10, 2019

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)
Panretin
Generic name (nonproprietary)
alitretinoin
Active ingredients
Alitretinoin — 60 mg/60g
Dosage form
Gel
Route
Topical
Labeler
Advanz Pharma (US) Corp.NDC labeler code 59212
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020886
Marketing start
Listing expires
Other FDA classes
Retinoids (Chemical structure)
Identifiers
Product ID 59212-601_5b7465cd-3367-44ee-a11d-d021d6400a23SPL ID 5b7465cd-3367-44ee-a11d-d021d6400a23SPL set ID 49c16717-7d86-4257-80c9-baa1417e5555RxCUI 213502, 313847UNII 1UA8E65KDZUPC 0359212601223
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

N459212060122 followed by a unit qualifier and the quantity

Package 59212-0601-22. 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)

1.1 Kaposi’s Sarcoma PANRETIN GEL is indicated for topical treatment of cutaneous lesions in adults with AIDS related Kaposi’s sarcoma (KS). Limitations of Use: PANRETIN GEL is not indicated when systemic anti-KS therapy is required (including more than 10 new KS lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary KS, or symptomatic visceral involvement) [see Clinical Studies ( 14.1 )] . PANRETIN GEL is a retinoid indicated for the topical treatment of cutaneous lesions in adults with AIDS-related Kaposi’s sarcoma (KS). Limitations of Use : PANRETIN GEL is not indicated when systemic anti-Kaposi’s sarcoma therapy is required.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59212-601

What is NDC 59212-601?
59212-601 is the product NDC for Panretin (alitretinoin), Alitretinoin 60 mg/60g gel, listed with the FDA by Advanz Pharma (US) Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Panretin (Alitretinoin).
What is the active ingredient?
Alitretinoin.
Who is the labeler?
Advanz Pharma (US) Corp., NDC labeler code 59212. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Panretin?
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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