Prescription drug · ANDA
Lidocaine and Prilocaine NDC 46708-582
Lidocaine 25 mg/g; Prilocaine 25 mg/g · Cream · Topical · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-582-04 | 46708058204 | 1 TUBE in 1 CARTON (46708-582-04) / 5 g in 1 TUBEMarketed from Apr 3, 2025 | |
| 46708-582-31 | 46708058231 | 1 TUBE in 1 CARTON (46708-582-31) / 30 g in 1 TUBEMarketed from Apr 3, 2025 |
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
- Generic name (nonproprietary)
- lidocaine and prilocaine
- Active ingredients
- Lidocaine — 25 mg/gPrilocaine — 25 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213923
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Amides (Chemical structure)Local Anesthesia (Physiologic effect)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 46708-582_59488591-1d11-453f-b2f2-b2a47825819aSPL ID 59488591-1d11-453f-b2f2-b2a47825819aSPL set ID 54198bf6-c93c-42cd-9b2b-63918eb32880RxCUI 197877UNII 98PI200987, 046O35D44RUPC 0346708582043
- 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
N446708058204followed by a unit qualifier and the quantityPackage 46708-0582-04. 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 (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 46708-582
- What is NDC 46708-582?
- 46708-582 is the product NDC for Lidocaine and Prilocaine, Lidocaine 25 mg/g; Prilocaine 25 mg/g cream, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lidocaine and Prilocaine.
- What is the active ingredient?
- Lidocaine, Prilocaine.
- Who is the labeler?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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?
- 15 other product NDCs are listed under this name. See all Lidocaine and Prilocaine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lidocaine and Prilocaine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lidocaine And Prilocaine | Lidocaine 25 mg/g; Prilocaine 25 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-4090 | 68788-4090-03 |
| Lidocaine and prilocaine | Lidocaine 25 mg/g; Prilocaine 25 mg/g | CreamTopical | A-S Medication Solutions | 50090-8089 | 50090-8089-00 |
| Lidocaine and prilocaine | Lidocaine 25 mg/g; Prilocaine 25 mg/g | CreamTopical | Zydus Lifesciences Limited | 70771-1872 | 70771-1872-0270771-1872-08 |
| Lidocaine and prilocaine | Lidocaine 25 mg/g; Prilocaine 25 mg/g | CreamTopical | Viona Pharmaceuticals Inc | 72578-165 | 72578-0165-0672578-0165-96 |
| Lidocaine And Prilocaine | Lidocaine 25 mg/g; Prilocaine 25 mg/g | CreamTopical | Padagis US LLC | 0574-2042 | 00574-2042-30 |
| Lidocaine And Prilocaine | Lidocaine 25 mg/g; Prilocaine 25 mg/g | CreamTopical | A-S Medication Solutions | 50090-6589 | 50090-6589-00 |
| Lidocaine And Prilocaine | Lidocaine 25 mg/g; Prilocaine 25 mg/g | CreamTopical | NuCare Pharmaceuticals, Inc. | 68071-3856 | 68071-3856-03 |
| Lidocaine And Prilocaine | Lidocaine 25 mg/g; Prilocaine 25 mg/g | CreamTopical | Bryant Ranch Prepack | 71335-2716 | 71335-2716-01 |
| Lidocaine And Prilocaine | Lidocaine 25 mg/g; Prilocaine 25 mg/g | CreamTopical | Bryant Ranch Prepack | 71335-2970 | 71335-2970-01 |
| Lidocaine And Prilocaine | Lidocaine 25 mg/g; Prilocaine 25 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-1125 | 72162-1125-03 |
Other NDCs under ANDA 213923
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 |
|---|---|---|---|---|
| Lidocaine and Prilocaine | Lidocaine 25 mg/g; Prilocaine 25 mg/g | CreamTopical | Alembic Pharmaceuticals Inc. | 62332-582 |