What is NDC 68462-609?

68462-609 is the product NDC for Pimecrolimus, Pimecrolimus 10 mg/g cream, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 3 package NDCs, shown above in 10- and 11-digit form.

Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Pimecrolimus?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pimecrolimus NDC 68462-609 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-609Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0609Add 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
68462-609-35	6846206093568462060935	1 TUBE in 1 CARTON (68462-609-35) / 30 g in 1 TUBEMarketed from Aug 29, 2019
68462-609-65	6846206096568462060965	1 TUBE in 1 CARTON (68462-609-65) / 60 g in 1 TUBEMarketed from Aug 29, 2019
68462-609-94	6846206099468462060994	1 TUBE in 1 CARTON (68462-609-94) / 100 g in 1 TUBEMarketed from Aug 29, 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): Pimecrolimus
Generic name (nonproprietary): pimecrolimus
Active ingredients: Pimecrolimus — 10 mg/g
Dosage form: Cream
Route: Topical
Labeler: Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211769
Marketing start: Aug 29, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Calcineurin Inhibitors (Mechanism)
Identifiers: Product ID 68462-609_693578a9-44f8-442b-b186-ccb367cc7cf0SPL ID 693578a9-44f8-442b-b186-ccb367cc7cf0SPL set ID ac52a235-1b6f-47a2-b3d9-8d538eeae02fRxCUI 562806UNII 7KYV510875UPC 0368462609354
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

N468462060935 followed by a unit qualifier and the quantity

Package 68462-0609-35. 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 Oct 28, 2025. 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 dermatit…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68462-609

What is NDC 68462-609?: 68462-609 is the product NDC for Pimecrolimus, Pimecrolimus 10 mg/g cream, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Pimecrolimus.
What is the active ingredient?: Pimecrolimus.
Who is the labeler?: Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pimecrolimus?: 5 other product NDCs are listed under this name. See all Pimecrolimus NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Pimecrolimus NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
pimecrolimus	Pimecrolimus 10 mg/g	CreamTopical	Actavis Pharma, Inc.	0591-2944	00591-2944-3000591-2944-6000591-2944-87
Pimecrolimus	Pimecrolimus 10 mg/g	CreamTopical	Oceanside Pharmaceuticals	68682-110	68682-0110-01
Pimecrolimus	Pimecrolimus 10 mg/g	CreamTopical	Oceanside Pharmaceuticals	68682-111	68682-0111-02
Pimecrolimus	Pimecrolimus 10 mg/g	CreamTopical	Oceanside Pharmaceuticals	68682-112	68682-0112-03
Pimecrolimus	Pimecrolimus 10 mg/g	CreamTopical	Bryant Ranch Prepack	71335-2988	71335-2988-01