BENZONATATE

Product NDC: 51655-769
11-digit product format: 516550769
Labeler code: 51655
Product ID: 51655-769_280f9437-8d0e-1a25-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BENZONATATE
Dosage form: TABLET
Route: ORAL
Labeler: Northwind Pharmaceuticals, LLC
Application: ANDA040627
Marketing category: ANDA
Marketing start: 2014-12-08
Marketing end: 0000-00-00
Substance: BENZONATATE
Active strength: 100 mg/1
Pharmacologic classes: Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-769-52	2026-01-13	C162847	48780-1	9d75b9cf-fd01-f424-e053-dadaa90a57ce	9bbd5a37-2bc4-4522-af21-67719f98d97c
51655-769-85	2026-01-13	C162847	48780-1	9d75b9cf-fd01-f424-e053-dadaa90a57ce	9bbd5a37-2bc4-4522-af21-67719f98d97c
51655-769-52	2020-01-31	C162847	48780-1	9d75b9cf-fd01-f424-e053-dadaa90a57ce	9bbd5a37-2bc4-4522-af21-67719f98d97c
51655-769-85	2020-01-31	C162847	48780-1	9d75b9cf-fd01-f424-e053-dadaa90a57ce	9bbd5a37-2bc4-4522-af21-67719f98d97c

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-769	BENZONATATE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	2	Legacy NDC	20151230_9bbd5a37-2bc4-4522-af21-67719f98d97c.zip