Prescription drug · ANDA
Pimecrolimus NDC 68462-609
Pimecrolimus 10 mg/g · Cream · Topical · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-609-35 | 68462060935 | 1 TUBE in 1 CARTON (68462-609-35) / 30 g in 1 TUBEMarketed from Aug 29, 2019 | |
| 68462-609-65 | 68462060965 | 1 TUBE in 1 CARTON (68462-609-65) / 60 g in 1 TUBEMarketed from Aug 29, 2019 | |
| 68462-609-94 | 68462060994 | 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211769
- Marketing start
- Listing expires
- 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
N468462060935followed by a unit qualifier and the quantityPackage 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 . 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.