benzonatate

Product NDC: 52959-411
11-digit product format: 529590411
Labeler code: 52959
Product ID: 52959-411_1f3bb40a-4eff-4c11-b55b-89a3f8425118
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: benzonatate
Dosage form: CAPSULE
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA040627
Marketing category: ANDA
Marketing start: 2007-07-25
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: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52959-411-10	2019-11-13	C162847	48780-1	97449f38-d439-f6ea-e053-dbdaa90aa703	18e689cf-f504-464f-88d6-cc89aa05a6fc
52959-411-15	2019-11-13	C162847	48780-1	97449f38-d439-f6ea-e053-dbdaa90aa703	18e689cf-f504-464f-88d6-cc89aa05a6fc
52959-411-20	2019-11-13	C162847	48780-1	97449f38-d439-f6ea-e053-dbdaa90aa703	18e689cf-f504-464f-88d6-cc89aa05a6fc
52959-411-30	2019-11-13	C162847	48780-1	97449f38-d439-f6ea-e053-dbdaa90aa703	18e689cf-f504-464f-88d6-cc89aa05a6fc

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-411-10	benzonatate	10 in 1 BOTTLE	CAPSULE	10	2
52959-411-15	benzonatate	15 in 1 BOTTLE	CAPSULE	15	2
52959-411-20	benzonatate	20 in 1 BOTTLE	CAPSULE	20	2
52959-411-30	benzonatate	30 in 1 BOTTLE	CAPSULE	30	2

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-411-10	EA - Each	52959-411	4df52c75-819f-43a2-b344-0cc1ddc27982	1	2012-07-24
52959-411-15	EA - Each	52959-411	9a8475d1-383e-4393-9391-736ab774338f	1	2012-07-24
52959-411-20	EA - Each	52959-411	5c256872-f6ee-4da5-baf5-625bd3194a04	1	2012-07-24
52959-411-30	EA - Each	52959-411	75eba1b2-f2d3-40ed-84d5-cff1fb6609bb	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
benzonatate	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
benzonatate	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
gelatin	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-411	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2	Legacy NDC, 4 package rows	20120120_18e689cf-f504-464f-88d6-cc89aa05a6fc.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197397	benzonatate 100 MG Oral Capsule	PSN	18e689cf-f504-464f-88d6-cc89aa05a6fc	2
283417	benzonatate 200 MG Oral Capsule	PSN	18e689cf-f504-464f-88d6-cc89aa05a6fc	2
197397	benzonatate 100 MG Oral Capsule	SCD	18e689cf-f504-464f-88d6-cc89aa05a6fc	2
283417	benzonatate 200 MG Oral Capsule	SCD	18e689cf-f504-464f-88d6-cc89aa05a6fc	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-411-10	52959041110	10 in 1 BOTTLE	Historical
52959-411-15	52959041115	15 in 1 BOTTLE	Historical
52959-411-20	52959041120	20 in 1 BOTTLE	Historical
52959-411-30	52959041130	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
benzonatate - H.J. Harkins Company, Inc.	H.J. Harkins Company, Inc.	2012-01-19	HUMAN PRESCRIPTION DRUG LABEL	2