benzonatate

Product NDC: 67877-106
11-digit product format: 678770106
Labeler code: 67877
Product ID: 67877-106_de64cd7e-65b6-4ba2-8ed7-a1c98f2cca4e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: benzonatate
Dosage form: CAPSULE
Route: ORAL
Labeler: Ascend Laboratories LLC
Application: ANDA040749
Marketing category: ANDA
Marketing start: 2007-07-25
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: 2020-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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
67877-106-01	2021-07-23	C162847	48780-1	c7ccaba7-1638-fd44-e053-dadaa90aa01b	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
67877-106-05	2021-07-23	C162847	48780-1	c7ccaba7-1638-fd44-e053-dadaa90aa01b	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67877-106-01	benzonatate	100 in 1 BOTTLE	CAPSULE	100		13
67877-106-05	benzonatate	500 in 1 BOTTLE	CAPSULE	500		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-106-01	EA - Each	67877-106	d87ceff9-b877-403b-a0a7-cf0123b10e92	1	2012-07-24
67877-106-05	EA - Each	67877-106	49f232d1-9f80-40e3-a327-afa6d05bf337	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
benzonatate	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]	11
benzonatate	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]	11
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]	11
gelatin	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]	11
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]	11
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]	11
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]	11
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]	11
water	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]	11
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]	4
benzonatate	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
benzonatate	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	2
benzonatate	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
benzonatate	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	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
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	2
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	2
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	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
WATER	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [UNIT DOSE SERVICES]	2
benzonatate	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	1
benzonatate	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
benzonatate	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	1
benzonatate	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [REDPHARM DRUG INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-106	BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]	13	Legacy NDC, 2 package rows	20200101_27388883-e698-4501-b8c9-78c76ae9b1e1.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
197397	benzonatate 100 MG Oral Capsule	PSN	27388883-e698-4501-b8c9-78c76ae9b1e1	13
903291	benzonatate 150 MG Oral Capsule	PSN	27388883-e698-4501-b8c9-78c76ae9b1e1	13
283417	benzonatate 200 MG Oral Capsule	PSN	27388883-e698-4501-b8c9-78c76ae9b1e1	13
197397	benzonatate 100 MG Oral Capsule	SCD	27388883-e698-4501-b8c9-78c76ae9b1e1	13
903291	benzonatate 150 MG Oral Capsule	SCD	27388883-e698-4501-b8c9-78c76ae9b1e1	13
283417	benzonatate 200 MG Oral Capsule	SCD	27388883-e698-4501-b8c9-78c76ae9b1e1	13
197397	benzonatate 100 MG Oral Capsule	PSN	00acfc04-3ad0-487e-87dd-e6e632c05b45	4
283417	benzonatate 200 MG Oral Capsule	PSN	1e998229-51ef-464d-af9f-80c5ce88b8a7	4
283417	benzonatate 200 MG Oral Capsule	PSN	00acfc04-3ad0-487e-87dd-e6e632c05b45	4
197397	benzonatate 100 MG Oral Capsule	SCD	00acfc04-3ad0-487e-87dd-e6e632c05b45	4
283417	benzonatate 200 MG Oral Capsule	SCD	1e998229-51ef-464d-af9f-80c5ce88b8a7	4
283417	benzonatate 200 MG Oral Capsule	SCD	00acfc04-3ad0-487e-87dd-e6e632c05b45	4
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
197397	benzonatate 100 MG Oral Capsule	PSN	15dd2f41-952b-40d2-a9bb-5e1cb8802e5e	1
197397	benzonatate 100 MG Oral Capsule	PSN	3c92ce07-da4e-47f0-ba1a-84f6a758bf17	1
283417	benzonatate 200 MG Oral Capsule	PSN	446d268a-fc0f-4027-b380-1083a3a252b5	1
283417	benzonatate 200 MG Oral Capsule	PSN	3c92ce07-da4e-47f0-ba1a-84f6a758bf17	1
283417	benzonatate 200 MG Oral Capsule	PSN	15dd2f41-952b-40d2-a9bb-5e1cb8802e5e	1
197397	benzonatate 100 MG Oral Capsule	SCD	3c92ce07-da4e-47f0-ba1a-84f6a758bf17	1
197397	benzonatate 100 MG Oral Capsule	SCD	15dd2f41-952b-40d2-a9bb-5e1cb8802e5e	1
283417	benzonatate 200 MG Oral Capsule	SCD	3c92ce07-da4e-47f0-ba1a-84f6a758bf17	1
283417	benzonatate 200 MG Oral Capsule	SCD	15dd2f41-952b-40d2-a9bb-5e1cb8802e5e	1
283417	benzonatate 200 MG Oral Capsule	SCD	446d268a-fc0f-4027-b380-1083a3a252b5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-106-01	67877010601	100 CAPSULE in 1 BOTTLE (67877-106-01)	100 capsule	2007-07-25	0000-00-00	No	No	Current
67877-106-05	67877010605	500 CAPSULE in 1 BOTTLE (67877-106-05)	500 capsule	2007-07-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	Ascend Laboratories LLC \| Intergel Pharmaceuticals Inc	2019-12-31	HUMAN PRESCRIPTION DRUG LABEL	13
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	Unit Dose Services	2017-03-06	HUMAN PRESCRIPTION DRUG LABEL	4
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	Blenheim Pharmacal, Inc.	2015-02-25	HUMAN PRESCRIPTION DRUG LABEL	4
BENZONATATE CAP 100MG 200MG FOR INTERGEL	Aidarex Pharmaceuticals LLC	2013-12-12	HUMAN PRESCRIPTION DRUG LABEL	1
benzonatate - H.J. Harkins Company, Inc.	H.J. Harkins Company, Inc.	2012-01-19	HUMAN PRESCRIPTION DRUG LABEL	2
Benzoate Capsules	RedPharm Drug Inc. \| INTERGEL PHARMACEUTICAL, INC.	2011-08-08	HUMAN PRESCRIPTION DRUG LABEL	1
benzonatate - Rebel Distributors Corp	Rebel Distributors Corp	2011-04-13	HUMAN PRESCRIPTION DRUG LABEL	1

benzonatate

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#