NDC codes

FDA NDC Directory
Product NDC (as listed)13913-012Labeler and product segments. Claims need a package NDC.
Product NDC at billing width13913-0012Add 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 NDC11-digit (billing)PackageCopy
13913-012-02139130012029 PACKET in 1 CARTON (13913-012-02) / 1 POWDER, FOR SOLUTION in 1 PACKETMarketed from Mar 10, 2016
13913-012-03139130012039 PACKET in 1 CARTON (13913-012-03) / 1 POWDER, FOR SOLUTION in 1 PACKET (13913-012-01)Marketed from Mar 10, 2016

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)
Cambia
Generic name (nonproprietary)
diclofenac potassium
Active ingredients
Diclofenac potassium — 50 mg/1
Dosage form
Powder, For solution
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 022165
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers
Product ID 13913-012_b9a3d927-3dc3-4860-ac3b-3dd20df47dd6SPL ID b9a3d927-3dc3-4860-ac3b-3dd20df47dd6SPL set ID d249ced1-4ca0-4f57-adcb-23440f58f659RxCUI 859063, 859066UNII L4D5UA6CB4

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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N413913001202 followed by a unit qualifier and the quantity

Package 13913-0012-02. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

CAMBIA is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Limitations of Use: CAMBIA is not indicated for the prophylactic therapy of migraine. The safety and effectiveness of CAMBIA have not been established for cluster headache, which is present in an older, predominantly male population. CAMBIA is a non-steroidal anti-inflammatory drug (NSAID) indicated for the acute treatment of migraine attacks with or without aura in adults 18 years of age or older ( 1 ) Limitations of Use ( 1 ): CAMBIA is not indicated for the prophylactic therapy of migraine Safety and effectiveness of CAMBIA not established for cluster headache, which …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022165

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

FDA NDC Directory listings under NDA 022165
ProductStrengthForm · routeLabelerProduct NDC
Diclofenac PotassiumDiclofenac potassium 50 mg/1Powder, For solutionOralLeading Pharma, LLC69315-506

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