Pimecrolimus NDC 68682-111

NDC codes

FDA NDC Directory

Product NDC (as listed)68682-111Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68682-0111Add 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
68682-111-02	68682011102	1 TUBE in 1 CARTON (68682-111-02) / 60 g in 1 TUBEMarketed from Nov 26, 2018

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): Pimecrolimus
Generic name (nonproprietary): pimecrolimus
Active ingredients: Pimecrolimus — 10 mg/g
Dosage form: Cream
Route: Topical
Labeler: Oceanside Pharmaceuticals
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 021302
Marketing start: Nov 26, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Calcineurin Inhibitors (Mechanism)
Identifiers: Product ID 68682-111_e391204d-95f9-4c57-a0db-578bdd1b8bdeSPL ID e391204d-95f9-4c57-a0db-578bdd1b8bdeSPL set ID 6601e43e-ce7d-446a-8568-8e7b24b86f06RxCUI 562806UNII 7KYV510875UPC 0368682111026, 0368682112030, 0368682110012
Pharmacologic class: Calcineurin Inhibitor Immunosuppressant

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

N468682011102 followed by a unit qualifier and the quantity

Package 68682-0111-02. 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 Apr 30, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Pimecrolimus Cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. Pimecrolimus Cream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ] . Pimecrolimus Cream, 1% is a calcineurin inhibitor immunosuppressant indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermati…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021302

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

FDA NDC Directory listings under NDA 021302
Product	Strength	Form · route	Labeler	Product NDC
Pimecrolimus	Pimecrolimus 10 mg/g	CreamTopical	Oceanside Pharmaceuticals	68682-112
Pimecrolimus	Pimecrolimus 10 mg/g	CreamTopical	Oceanside Pharmaceuticals	68682-110
Pimecrolimus	Pimecrolimus 10 mg/g	CreamTopical	Bryant Ranch Prepack	71335-2988