NDC 10885-002

Synera

Lidocaine And Tetracaine

Synera is a Cutaneous Patch in the Human Prescription Drug category. It is labeled and distributed by Galen Us Incorporated. The primary component is Lidocaine; Tetracaine.

• Product ID: 10885-002_7aa261d1-15a8-e0ab-e053-2a91aa0ad2a0
• NDC: 10885-002
• Product Type: Human Prescription Drug
• Proprietary Name: Synera
• Generic Name: Lidocaine And Tetracaine
• Dosage Form: Patch
• Route of Administration: CUTANEOUS
• Marketing Start Date: 2013-12-01
• Marketing Category: NDA / NDA
• Application Number: NDA021623
• Labeler Name: Galen US Incorporated
• Substance Name: LIDOCAINE; TETRACAINE
• Active Ingredient Strength: 70 mg/1; mg/1
• 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: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 10885-002-01

1 PATCH in 1 POUCH (10885-002-01)

• Marketing Start Date: 2013-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10885-002-01 [10885000201]

Synera PATCH

• Marketing Category: NDA
• Application Number: NDA021623
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-12-01

NDC 10885-002-10 [10885000210]

Synera PATCH

• Marketing Category: NDA
• Application Number: NDA021623
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-12-01

Drug Details

Active Ingredients

Ingredient	Strength
LIDOCAINE	70 mg/1

OpenFDA Data

• SPL SET ID: 5f86a348-2274-4945-8694-4c1f0050bf02
• Manufacturer:
  • Galen US Incorporated
• UNII:
  • 98PI200987
  • 0619F35CGV
• RxNorm Concept Unique ID - RxCUI:
  • 644287
  • 644290

Pharmacological Class

• Amide Local Anesthetic [EPC]
• Amides [CS]
• Antiarrhythmic [EPC]
• Local Anesthesia [PE]
• Esters [CS]
• Local Anesthesia [PE]
• Ester Local Anesthetic [EPC]
• 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 "Synera" or generic name "Lidocaine And Tetracaine"

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