Prescription drug · NDA AUTHORIZED GENERIC
Pimecrolimus NDC 71335-2988
Pimecrolimus 10 mg/g · Cream · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2988-1 | 71335298801 | 1 TUBE in 1 CARTON (71335-2988-1) / 30 g in 1 TUBEMarketed from Nov 10, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021302
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-2988_d322797e-793d-4ad3-b13b-e57717a4e022SPL ID d322797e-793d-4ad3-b13b-e57717a4e022SPL set ID dc8708ec-16be-4c27-8a5e-bf84723408feRxCUI 562806UNII 7KYV510875
- 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
N471335298801followed by a unit qualifier and the quantityPackage 71335-2988-01. 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 dermati…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021302
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 | Oceanside Pharmaceuticals | 68682-111 |