benzonatate

Product NDC: 67877-574
11-digit product format: 678770574
Labeler code: 67877
Product ID: 67877-574_30b1db37-0e38-428e-a568-6ccc3ec605a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: benzonatate
Dosage form: CAPSULE
Route: ORAL
Labeler: Ascend Laboratories LLC
Application: ANDA201209
Marketing category: ANDA
Marketing start: 2017-03-22
Marketing end: 0000-00-00
Substance: BENZONATATE
Active strength: 150 mg/1
Pharmacologic classes: Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67877-574-01	2024-11-23	C162847	48780-1	c7ccaba7-27d8-fd44-e053-dadaa90aa01b	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
67877-574-01	2021-07-23	C162847	48780-1	c7ccaba7-27d8-fd44-e053-dadaa90aa01b	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-574-01	EA - Each	67877-574	3171b199-a670-455d-bbbf-15c70bcafd7a	1	2017-11-06

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5P4DHS6ENR	BENZONATATE	104-31-4	BENZONATATE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-574-01	67877057401	100 CAPSULE in 1 BOTTLE (67877-574-01)	100 capsule	2017-03-22	0000-00-00	No	No	Current