benzonatate

Product NDC: 67296-1583
11-digit product format: 672961583
Labeler code: 67296
Product ID: 67296-1583_9c9fd8a4-488c-75a5-e053-2995a90a626a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: benzonatate
Dosage form: CAPSULE
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA040749
Marketing category: ANDA
Marketing start: 2018-01-01
Marketing end: 0000-00-00
Substance: BENZONATATE
Active strength: 200 mg/1
Pharmacologic classes: Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	67296-1583		I	Inactivated by FDA		2026-07-31
excluded package	package	67296-1583	67296-1583-3	I	Inactivated by FDA		2026-07-31

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
benzonatate	BENZONATATE	Bryant Ranch Prepack	a788cb01-6dc3-4f28-aaa0-c23ac058c39a	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040749 application number: ANDA040749
benzonatate	BENZONATATE	Proficient Rx LP	9566b9b9-54ef-423c-8ce4-0f1714052158	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040749 application number: ANDA040749
benzonatate	BENZONATATE	Proficient Rx LP	27156dad-64d6-4ea4-a3da-29e8e096fb01	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040749 application number: ANDA040749

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dc429dc2-e942-6686-8d72-b63c57e806aa	Product name	5	20190416
d45c2ed6-126c-dd22-afd2-e29a2ecf77b9	Product name	3	20190215

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-1583-3	2024-08-15	C162847	48780-1	d6a99b39-9fd5-a426-e053-dadaa90af4c2	benzonatate
67296-1583-3	2022-01-28	C162847	48780-1	d6a99b39-9fd5-a426-e053-dadaa90af4c2	benzonatate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1583-3	benzonatate	30 in 1 BOTTLE	CAPSULE	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1583	BENZONATATE CAPSULE [REDPHARM DRUG, INC.]	3	Legacy NDC, 1 package rows	20240816_6a100c5c-ec5e-29a3-e053-2991aa0aa3b0.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
283417	benzonatate 200 MG Oral Capsule	PSN	6a100c5c-ec5e-29a3-e053-2991aa0aa3b0	3
283417	benzonatate 200 MG Oral Capsule	SCD	6a100c5c-ec5e-29a3-e053-2991aa0aa3b0	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1583-3	67296158303	30 CAPSULE in 1 BOTTLE (67296-1583-3)	30 capsule	2018-01-01	0000-00-00	No	No	Current