NDC 0069-0122

Tessalon

Benzonatate

Tessalon is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Benzonatate.

• Product ID: 0069-0122_5ba6c016-650c-4f35-a2c3-98c4f0507046
• NDC: 0069-0122
• Product Type: Human Prescription Drug
• Proprietary Name: Tessalon
• Generic Name: Benzonatate
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1958-02-10
• Marketing Category: NDA / NDA
• Application Number: NDA011210
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: BENZONATATE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0069-0122-01

100 CAPSULE in 1 BOTTLE (0069-0122-01)

• Marketing Start Date: 1958-02-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0069-0122-02 [00069012202]

Tessalon CAPSULE

• Marketing Category: NDA
• Application Number: NDA011210
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1958-02-10
• Marketing End Date: 2013-07-31

NDC 0069-0122-01 [00069012201]

Tessalon CAPSULE

• Marketing Category: NDA
• Application Number: NDA011210
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1958-02-10

Drug Details

Active Ingredients

Ingredient	Strength
BENZONATATE	100 mg/1

OpenFDA Data

• SPL SET ID: 8edd07a0-5f5b-9000-bafb-dbf8ff7609d4
• Manufacturer:
  • Pfizer Laboratories Div Pfizer Inc
• UNII:
  • 5P4DHS6ENR
• RxNorm Concept Unique ID - RxCUI:
  • 208365
  • 197397
• UPC Code:
  • 0300690122014

Pharmacological Class

• Decreased Tracheobronchial Stretch Receptor Activity [PE]
• Non-narcotic Antitussive [EPC]

NDC Crossover Matching brand name "Tessalon" or generic name "Benzonatate"

NDC	Brand Name	Generic Name
0069-0122	Tessalon	benzonatate
0179-0237	benzonatate	benzonatate
0440-1185	benzonatate	benzonatate
0440-5185	benzonatate	benzonatate
0440-5186	benzonatate	benzonatate
0440-5187	benzonatate	benzonatate
0440-7185	benzonatate	benzonatate
0440-7186	benzonatate	benzonatate
0615-1349	Benzonatate	Benzonatate
0615-7678	Benzonatate	Benzonatate
0615-7887	benzonatate	benzonatate
0615-8143	benzonatate	benzonatate
0615-8194	benzonatate	benzonatate
0615-8403	Benzonatate	Benzonatate
0904-5904	benzonatate	benzonatate
0904-5905	benzonatate	benzonatate
0904-6564	Benzonatate	Benzonatate
0904-6657	benzonatate	benzonatate
0904-7153	Benzonatate	Benzonatate
10135-632	Benzonatate	Benzonatate
10544-094	benzonatate	benzonatate
10544-123	benzonatate	benzonatate
10544-129	benzonatate	benzonatate
11788-027	benzonatate	benzonatate
11788-028	benzonatate	benzonatate
11788-029	benzonatate	benzonatate