HYOSCYAMINE SULFATE

Product NDC: 54288-111
11-digit product format: 542880111
Labeler code: 54288
Product ID: 54288-111_ba3bb8f4-5954-40a8-a072-2f75edb2c102
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: HYOSCYAMINE SULFATE
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: BPI Labs LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2019-10-18
Substance: HYOSCYAMINE SULFATE
Active strength: .5 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: HYOSCYAMINE SULFATE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYOSCYAMINE SULFATE	.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F2R8V82B84	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1047916	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6c0a1fef-c634-4ecf-9850-d188e6496b90	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54288-111-01	HYOSCYAMINE SULFATE	1 mL in 1 VIAL	INJECTION, SOLUTION	1		10
54288-111-05	HYOSCYAMINE SULFATE	5 in 1 CARTON	INJECTION, SOLUTION	5		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54288-111-01	ML - Milliliter	54288-111	0017a589-20e0-4166-b053-9f0fd097047d	1	2019-11-12
54288-111-05	ML - Milliliter	54288-111	2073e957-68f3-4078-adc6-3256195cbe78	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54288-111	HYOSCYAMINE SULFATE INJECTION, SOLUTION [BPI LABS LLC]	9	Current NDC, Legacy NDC, 2 package rows	20250213_6c0a1fef-c634-4ecf-9850-d188e6496b90.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYOSCYAMINE SULFATE	HYOSCYAMINE SULFATE	BPI Labs LLC	6c0a1fef-c634-4ecf-9850-d188e6496b90	2025-12-26	Warnings, Adverse reactions	Exact identifier ndc (product): 54288-111

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F2R8V82B84	HYOSCYAMINE SULFATE	6835-16-1	HYOSCYAMINE SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1047916	hyoscyamine sulfate 0.5 MG in 1 ML Injection	PSN	6c0a1fef-c634-4ecf-9850-d188e6496b90	10
1047916	1 ML hyoscyamine sulfate 0.5 MG/ML Injection	SCD	6c0a1fef-c634-4ecf-9850-d188e6496b90	10
1047916	hyoscyamine sulfate 0.5 MG per 1 ML Injection	SY	6c0a1fef-c634-4ecf-9850-d188e6496b90	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54288-111-01	54288011101	1 mL in 1 VIAL	1 ml					Historical
54288-111-05	54288011105	5 VIAL in 1 CARTON (54288-111-05) / 1 mL in 1 VIAL (54288-111-01)	5 vial	2019-10-18	0000-00-00	No	No	Current