Benzonatate

Product NDC: 72789-231
11-digit product format: 727890231
Labeler code: 72789
Product ID: 72789-231_2d6c8ca3-bf6c-22a9-e063-6294a90a2029
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Benzonatate
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA206948
Marketing category: ANDA
Marketing start: 2018-12-21
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: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 72789-231_2d6c8ca3-bf6c-22a9-e063-6294a90a2029
SPL ID: 2d6c8ca3-bf6c-22a9-e063-6294a90a2029
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Benzonatate
Generic name: Benzonatate
Dosage form: CAPSULE
Route: ORAL
Marketing start: 2018-12-21
Marketing category: ANDA
Application number: ANDA206948
Pharmacologic classes: Decreased Tracheobronchial Stretch Receptor Activity [PE]; Non-narcotic Antitussive [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
BENZONATATE	100 mg/1

Package NDC	Description	Marketing start	Sample
72789-231-15	15 CAPSULE in 1 BOTTLE, PLASTIC (72789-231-15)	2022-02-08	No

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

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72789-231-15	72789023115	15 CAPSULE in 1 BOTTLE, PLASTIC (72789-231-15)	15 capsule	2022-02-08	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Benzonatate Capsules, USP	PD-Rx Pharmaceuticals, Inc.	2025-02-05	HUMAN PRESCRIPTION DRUG LABEL	5