Bisoprolol Fumarate

Product NDC: 29300-126
11-digit product format: 293000126
Labeler code: 29300
Product ID: 29300-126_958d523d-b040-4475-ad89-6278e5cf0f60
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bisoprolol fumarate
Dosage form: TABLET
Route: ORAL
Labeler: Unichem Pharmaceuticals (USA), Inc.
Application: ANDA078635
Marketing category: ANDA
Marketing start: 2009-09-21
Substance: BISOPROLOL FUMARATE
Active strength: 5 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Bisoprolol Fumarate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BISOPROLOL FUMARATE	5 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	UR59KN573L
Rxcui	854901, 854905

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
97e4a60d-917d-ef62-dc8a-bd557b62b708	Product name	7	20260129
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
29300-126-01	Bisoprolol Fumarate	100 in 1 BOTTLE, PLASTIC	TABLET	100	11
29300-126-05	Bisoprolol Fumarate	500 in 1 BOTTLE, PLASTIC	TABLET	500	11
29300-126-13	Bisoprolol Fumarate	30 in 1 BOTTLE, PLASTIC	TABLET	30	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29300-126-01	EA - Each	29300-126	7d882a5f-30e5-416e-8aee-e752e742687e	1	2012-07-24
29300-126-13	EA - Each	29300-126	b3f5ed02-8c92-4172-9af8-70ba64dc095f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BISOPROLOL FUMARATE	ACTIVE INGREDIENT	UR59KN573L	BISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]	1000
BISOPROLOL	ACTIVE MOIETY	Y41JS2NL6U	BISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]	1000
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	BISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]	1000
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]	1000
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]	1000
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	BISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]	1000
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	BISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	BISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]	1000
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	BISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]	1000
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]	1000
BISOPROLOL FUMARATE	ACTIVE INGREDIENT	UR59KN573L	BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
BISOPROLOL	ACTIVE MOIETY	Y41JS2NL6U	BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	4
BISOPROLOL FUMARATE	ACTIVE INGREDIENT	UR59KN573L	BISOPROLOL FUMARATE TABLET [CARILION MATERIALS MANAGEMENT]	2
BISOPROLOL	ACTIVE MOIETY	Y41JS2NL6U	BISOPROLOL FUMARATE TABLET [CARILION MATERIALS MANAGEMENT]	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	BISOPROLOL FUMARATE TABLET [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BISOPROLOL FUMARATE TABLET [CARILION MATERIALS MANAGEMENT]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BISOPROLOL FUMARATE TABLET [CARILION MATERIALS MANAGEMENT]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BISOPROLOL FUMARATE TABLET [CARILION MATERIALS MANAGEMENT]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	BISOPROLOL FUMARATE TABLET [CARILION MATERIALS MANAGEMENT]	2
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	BISOPROLOL FUMARATE TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BISOPROLOL FUMARATE TABLET [CARILION MATERIALS MANAGEMENT]	2
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	BISOPROLOL FUMARATE TABLET [CARILION MATERIALS MANAGEMENT]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	BISOPROLOL FUMARATE TABLET [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BISOPROLOL FUMARATE TABLET [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BISOPROLOL FUMARATE TABLET [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BISOPROLOL FUMARATE TABLET [CARILION MATERIALS MANAGEMENT]	2
BISOPROLOL FUMARATE	ACTIVE INGREDIENT	UR59KN573L	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
BISOPROLOL	ACTIVE MOIETY	Y41JS2NL6U	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29300-126	BISOPROLOL FUMARATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]	11	Current NDC, Legacy NDC, 3 package rows	20221029_4f20df45-3f9c-4a91-b394-e93a08111ec3.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UR59KN573L	BISOPROLOL FUMARATE	104344-23-2	BISOPROLOL FUMARATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
854905	bisoprolol fumarate 5 MG Oral Tablet	PSN	428ef54d-8828-4756-a087-a1b7b2d6b8d6	1011
854905	bisoprolol fumarate 5 MG Oral Tablet	SCD	428ef54d-8828-4756-a087-a1b7b2d6b8d6	1011
854901	bisoprolol fumarate 10 MG Oral Tablet	PSN	4f20df45-3f9c-4a91-b394-e93a08111ec3	11
854905	bisoprolol fumarate 5 MG Oral Tablet	PSN	4f20df45-3f9c-4a91-b394-e93a08111ec3	11
854901	bisoprolol fumarate 10 MG Oral Tablet	SCD	4f20df45-3f9c-4a91-b394-e93a08111ec3	11
854905	bisoprolol fumarate 5 MG Oral Tablet	SCD	4f20df45-3f9c-4a91-b394-e93a08111ec3	11
854905	bisoprolol fumarate 5 MG Oral Tablet	PSN	36b53e7f-e306-40a8-8d1b-d00695a4fe61	3
854905	bisoprolol fumarate 5 MG Oral Tablet	PSN	c0e309f3-82c3-4629-b790-fb8538b87369	3
854905	bisoprolol fumarate 5 MG Oral Tablet	SCD	c0e309f3-82c3-4629-b790-fb8538b87369	3
854905	bisoprolol fumarate 5 MG Oral Tablet	SCD	36b53e7f-e306-40a8-8d1b-d00695a4fe61	3
854905	bisoprolol fumarate 5 MG Oral Tablet	PSN	aca45d26-51c0-4257-9b5d-03e00e58196f	2
854905	bisoprolol fumarate 5 MG Oral Tablet	PSN	bce7e65a-148f-4ccd-9305-bc7331dbcca4	2
854905	bisoprolol fumarate 5 MG Oral Tablet	SCD	aca45d26-51c0-4257-9b5d-03e00e58196f	2
854905	bisoprolol fumarate 5 MG Oral Tablet	SCD	bce7e65a-148f-4ccd-9305-bc7331dbcca4	2
854901	bisoprolol fumarate 10 MG Oral Tablet	PSN	d82243b9-3e56-4a2b-8750-cb95ec106885	1
854905	bisoprolol fumarate 5 MG Oral Tablet	PSN	849ef938-530f-a4d2-e053-2991aa0a1c70	1
854905	bisoprolol fumarate 5 MG Oral Tablet	PSN	d82243b9-3e56-4a2b-8750-cb95ec106885	1
854901	bisoprolol fumarate 10 MG Oral Tablet	SCD	d82243b9-3e56-4a2b-8750-cb95ec106885	1
854905	bisoprolol fumarate 5 MG Oral Tablet	SCD	849ef938-530f-a4d2-e053-2991aa0a1c70	1
854905	bisoprolol fumarate 5 MG Oral Tablet	SCD	d82243b9-3e56-4a2b-8750-cb95ec106885	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29300-126-01	29300012601	100 TABLET in 1 BOTTLE, PLASTIC (29300-126-01)	100 tablet	2009-09-21	0000-00-00	No	No	Current
29300-126-05	29300012605	500 TABLET in 1 BOTTLE, PLASTIC (29300-126-05)	500 tablet	2016-08-19	0000-00-00	No	No	Current
29300-126-13	29300012613	30 TABLET in 1 BOTTLE, PLASTIC (29300-126-13)	30 tablet	2009-09-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bisoprolol Fumarate Tablets USP	Preferred Pharmaceuticals Inc.	2026-03-20	HUMAN PRESCRIPTION DRUG LABEL	3
Bisoprolol Fumarate Tablets USP Rx Only 8467901/0322F	American Health Packaging	2024-10-24	HUMAN PRESCRIPTION DRUG LABEL	3
Bisoprolol Fumarate Tablets USP	Bryant Ranch Prepack	2023-11-17	HUMAN PRESCRIPTION DRUG LABEL	1011
Bisoprolol Fumarate Tablets USP	Unichem Pharmaceuticals (USA), Inc.	2022-10-28	HUMAN PRESCRIPTION DRUG LABEL	11
Bisoprolol Fumarate Tablets USP	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	2
BISOPROLOL FUMARATE	DIRECTRX	2019-03-21	HUMAN PRESCRIPTION DRUG LABEL	1
Bisoprolol Fumarate Tablets USP	Carilion Materials Management	2011-09-23	HUMAN PRESCRIPTION DRUG LABEL	2
Bisoprolol Fumarate Tablets USP	Rebel Distributors Corp	2010-12-10	HUMAN PRESCRIPTION DRUG LABEL	1

Bisoprolol Fumarate

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

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#