NDC 53002-0410

benzonatate

Benzonatate

benzonatate is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Benzonatate.

• Product ID: 53002-0410_4fd60de2-4876-462f-9594-4663cb26d72b
• NDC: 53002-0410
• Product Type: Human Prescription Drug
• Proprietary Name: benzonatate
• Generic Name: Benzonatate
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2007-07-25
• Marketing Category: ANDA / ANDA
• Application Number: ANDA040749
• Labeler Name: RPK Pharmaceuticals, Inc.
• Substance Name: BENZONATATE
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 53002-0410-4

30 CAPSULE in 1 BOTTLE (53002-0410-4)

• Marketing Start Date: 2017-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53002-0410-4 [53002041004]

benzonatate CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA040749
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-01
• Inactivation Date: 2020-01-31

NDC 53002-0410-2 [53002041002]

benzonatate CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA040749
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-01
• Inactivation Date: 2020-01-31

NDC 53002-0410-1 [53002041001]

benzonatate CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA040749
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-01
• Inactivation Date: 2020-01-31

NDC 53002-0410-3 [53002041003]

benzonatate CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA040749
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-10-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
BENZONATATE	200 mg/1

OpenFDA Data

• SPL SET ID: 798c2d3f-6ebb-4b95-85f3-525693379d48
• Manufacturer:
  • RPK Pharmaceuticals, Inc.
• UNII:
  • 5P4DHS6ENR
• RxNorm Concept Unique ID - RxCUI:
  • 283417

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
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
67877-128	benzonatate	benzonatate
67877-105	benzonatate	benzonatate
67877-106	benzonatate	benzonatate
67877-575	benzonatate	benzonatate
67877-574	benzonatate	benzonatate
67877-573	benzonatate	benzonatate
68071-1891	benzonatate	benzonatate
68071-1984	benzonatate	benzonatate
68071-3185	benzonatate	benzonatate
68071-1877	Benzonatate	Benzonatate
68071-3204	benzonatate	benzonatate
68071-3346	benzonatate	benzonatate
68071-4317	benzonatate	benzonatate
68071-4105	Benzonatate	Benzonatate
68071-4258	benzonatate	benzonatate
68071-4337	benzonatate	benzonatate
68071-4276	benzonatate	benzonatate
68151-2697	Benzonatate	Benzonatate
68382-247	Benzonatate	Benzonatate
68382-248	Benzonatate	Benzonatate
68788-6357	Benzonatate	Benzonatate
68788-7014	Benzonatate	Benzonatate
68788-6839	Benzonatate	Benzonatate
68788-7087	benzonatate	benzonatate
68788-7094	benzonatate	benzonatate