Prescription drug · ANDA
Lidocaine And Prilocaine Lidocaine And Prilocaine (Lidocaine and prilocaine) NDC 21922-076
Lidocaine 25 mg/g; Prilocaine 25 mg/g · Cream · Topical · Encube Ethicals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21922-076-05 | 21922007605 | 1 TUBE in 1 CARTON (21922-076-05) / 30 g in 1 TUBEMarketed from Dec 12, 2024 |
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)
- Lidocaine And Prilocaine Lidocaine And PrilocaineSuffix: LIDOCAINE AND PRILOCAINE
- Generic name (nonproprietary)
- lidocaine and prilocaine
- Active ingredients
- Lidocaine — 25 mg/gPrilocaine — 25 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Encube Ethicals, Inc.NDC labeler code 21922
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076320
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Amides (Chemical structure)Local Anesthesia (Physiologic effect)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 21922-076_1273619a-0c04-4aef-83fd-818c077178d9SPL ID 1273619a-0c04-4aef-83fd-818c077178d9SPL set ID a65a29ca-9476-4290-9384-67df4caec655RxCUI 197877UNII 98PI200987, 046O35D44R
- 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
N421922007605followed by a unit qualifier and the quantityPackage 21922-0076-05. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Lidocaine and prilocaine cream USP, 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 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.
About NDC 21922-076
- What is NDC 21922-076?
- 21922-076 is the product NDC for Lidocaine And Prilocaine Lidocaine And Prilocaine, Lidocaine 25 mg/g; Prilocaine 25 mg/g cream, listed with the FDA by Encube Ethicals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lidocaine And Prilocaine Lidocaine And Prilocaine (Lidocaine and prilocaine).
- What is the active ingredient?
- Lidocaine, Prilocaine.
- Who is the labeler?
- Encube Ethicals, Inc., NDC labeler code 21922. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lidocaine And Prilocaine Lidocaine And Prilocaine?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.