Prescription drug · ANDA
diclofenac sodium NDC 45802-111
Diclofenac sodium 30 mg/g · Gel · Topical · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-111-01 | 45802011101 | 1 TUBE in 1 CARTON (45802-111-01) / 100 g in 1 TUBEMarketed from Nov 27, 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)
- diclofenac sodium
- Generic name (nonproprietary)
- diclofenac sodium
- Active ingredients
- Diclofenac sodium — 30 mg/g
- Dosage form
- Gel
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210893
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 45802-111_eeb0495b-abe8-4efe-bc64-17a7278dbe29SPL ID eeb0495b-abe8-4efe-bc64-17a7278dbe29SPL set ID 3f0f3514-c3f7-4dab-8e5f-ddf89adbe3b8RxCUI 855642UNII QTG126297Q
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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
N445802011101followed by a unit qualifier and the quantityPackage 45802-0111-01. 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)
Diclofenac sodium topical gel is indicated for the topical treatment of actinic keratoses (AK). Diclofenac sodium topical gel is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the topical treatment of actinic keratoses (AK). ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210893
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 |
|---|---|---|---|---|
| diclofenac sodium | Diclofenac sodium 30 mg/g | GelTopical | Bryant Ranch Prepack | 72162-1391 |
| diclofenac sodium | Diclofenac sodium 30 mg/g | GelTopical | Proficient Rx LP | 71205-692 |
| diclofenac sodium | Diclofenac sodium 30 mg/g | GelTopical | REMEDYREPACK INC. | 70518-2526 |
| diclofenac sodium | Diclofenac sodium 30 mg/g | GelTopical | NuCare Pharmaceuticals,Inc. | 68071-4859 |
| diclofenac sodium | Diclofenac sodium 30 mg/g | GelTopical | Bryant Ranch Prepack | 63629-2526 |