NDC 0299-6100

PLIAGLIS

Lidocaine And Tetracaine

PLIAGLIS is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Galderma Laboratories, L.p.. The primary component is Lidocaine; Tetracaine.

• Product ID: 0299-6100_20237304-10de-4a50-92d9-c073c14a6568
• NDC: 0299-6100
• Product Type: Human Prescription Drug
• Proprietary Name: PLIAGLIS
• Generic Name: Lidocaine And Tetracaine
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2006-06-29
• Marketing Category: NDA / NDA
• Application Number: NDA021717
• Labeler Name: Galderma Laboratories, L.P.
• Substance Name: LIDOCAINE; TETRACAINE
• Active Ingredient Strength: 70 mg/g; mg/g
• Pharm Classes: Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Esters [CS],Local Anesthesia [PE],Ester Local Anesthetic [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 0299-6100-10

1 TUBE in 1 CARTON (0299-6100-10) > 100 g in 1 TUBE

• Marketing Start Date: 2006-06-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0299-6100-60 [00299610060]

PLIAGLIS CREAM

• Marketing Category: NDA
• Application Number: NDA021717
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2006-06-29
• Marketing End Date: 2017-05-03

NDC 0299-6100-35 [00299610035]

PLIAGLIS CREAM

• Marketing Category: NDA
• Application Number: NDA021717
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2006-06-29
• Marketing End Date: 2017-05-03

NDC 0299-6100-00 [00299610000]

PLIAGLIS CREAM

• Marketing Category: NDA
• Application Number: NDA021717
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-11-15
• Marketing End Date: 2013-12-02

NDC 0299-6100-10 [00299610010]

PLIAGLIS CREAM

• Marketing Category: NDA
• Application Number: NDA021717
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2006-06-29
• Marketing End Date: 2017-05-03

NDC 0299-6100-30 [00299610030]

PLIAGLIS CREAM

• Marketing Category: NDA
• Application Number: NDA021717
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2006-06-29
• Marketing End Date: 2017-05-03

Drug Details

Active Ingredients

Ingredient	Strength
LIDOCAINE	70 mg/g

OpenFDA Data

• SPL SET ID: a80355e6-c235-4770-a2cd-240486874eaf
• Manufacturer:
  • Galderma Laboratories, L.P.
• UNII:
  • 98PI200987
  • 0619F35CGV
• RxNorm Concept Unique ID - RxCUI:
  • 728126
  • 687443
• UPC Code:
  • 0302996100109

Pharmacological Class

• Amide Local Anesthetic [EPC]
• Amides [CS]
• Antiarrhythmic [EPC]
• Local Anesthesia [PE]
• Esters [CS]
• Local Anesthesia [PE]
• Ester Local Anesthetic [EPC]

NDC Crossover Matching brand name "PLIAGLIS" or generic name "Lidocaine And Tetracaine"

NDC	Brand Name	Generic Name
0299-6100	PLIAGLIS	lidocaine and tetracaine
51672-5305	PLIAGLIS	Lidocaine and Tetracaine
73575-009	Pliaglis	lidocaine and tetracaine
73575-010	Pliaglis	lidocaine and tetracaine
69420-3077	LIDOCAINE AND TETRACAINE	LIDOCAINE AND TETRACAINE
71800-631	Lidocaine and Tetracaine	Lidocaine and Tetracaine
10885-002	Synera	lidocaine and tetracaine