Lidocaine and Prilocaine NDC 0168-0357

NDC codes

FDA NDC Directory

Product NDC (as listed)0168-0357Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00168-0357Add 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
0168-0357-30	00168035730	1 TUBE in 1 CARTON (0168-0357-30) / 30 g in 1 TUBEMarketed from Aug 18, 2003
0168-0357-55	00168035755	1 TUBE in 1 CARTON (0168-0357-55) / 5 g in 1 TUBE (0168-0357-05)Marketed from Jul 21, 2004
0168-0357-56	00168035756	1 TUBE in 1 CARTON (0168-0357-56) / 5 g in 1 TUBE (0168-0357-05)Marketed from Jul 21, 2004

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Lidocaine and Prilocaine
Generic name (nonproprietary): lidocaine and prilocaine
Active ingredients: Lidocaine — 25 mg/gPrilocaine — 25 mg/g
Dosage form: Cream
Route: Topical
Labeler: E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076453
Marketing start: Aug 18, 2003
Listing expires: Dec 31, 2027
Other FDA classes: Amides (Chemical structure)Amides (Chemical structure)Local Anesthesia (Physiologic effect)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 0168-0357_73a2a608-dd5c-4357-85f3-00358b9c6cccSPL ID 73a2a608-dd5c-4357-85f3-00358b9c6cccSPL set ID 833cd52c-6470-49c4-937f-1393971f4db9RxCUI 197877UNII 98PI200987, 046O35D44RUPC 0301680357300
Pharmacologic class: Amide Local Anesthetic; Antiarrhythmic

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

N400168035730 followed by a unit qualifier and the quantity

Package 00168-0357-30. 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 Jan 28, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Lidocaine and prilocaine cream, 2.5%/2.5% (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: - normal intact skin for local analgesia. - genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. Lidocaine and prilocaine cream, 2.5%/2.5% is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076453

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

FDA NDC Directory listings under ANDA 076453
Product	Strength	Form · route	Labeler	Product NDC
Lidocaine and Prilocaine	Lidocaine 25 mg/g; Prilocaine 25 mg/g	CreamTopical	Preferred Pharmaceuticals Inc.	68788-8150