Levsin

Product NDC: 68220-112
11-digit product format: 682200112
Labeler code: 68220
Product ID: 68220-112_b443f3e7-e3b1-4471-b924-a0c038b58d02
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hyoscyamine sulfate
Dosage form: TABLET
Route: ORAL
Labeler: Viatris Specialty LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 1955-06-01
Substance: HYOSCYAMINE SULFATE
Active strength: .125 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68220-112-50	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68220-112-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68220-112-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68220-112-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68220-112-50	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68220-112-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68220-112-50	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68220-112-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68220-112-50	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68220-112-10	`1332a3947898…`	`d4bfe170f9cd…`

Additional Listing Data#

Finished product: Yes
Brand name base: Levsin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYOSCYAMINE SULFATE	.125 mg/1

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1047905	Internal RxNorm lookup
1047907	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
32388e18-08de-455c-aad4-9c2264435f0f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68220-112-10	2024-11-01	32388e18-08de-455c-aad4-9c2264435f0f
68220-112-50	2024-11-01	32388e18-08de-455c-aad4-9c2264435f0f
68220-112-10	2024-01-30	32388e18-08de-455c-aad4-9c2264435f0f
68220-112-50	2024-01-30	32388e18-08de-455c-aad4-9c2264435f0f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68220-112-10	Levsin	100 in 1 BOTTLE	TABLET	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68220-112-10	EA - Each	68220-112	929fb6ff-9ec3-454e-b02d-354d8fbd2a37	1	2013-06-04
68220-112-50	EA - Each	68220-112	a814cb19-6223-4dd5-a1e1-17261b5532a1	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
HYOSCYAMINE SULFATE	ACTIVE INGREDIENT	F2R8V82B84	LEVSIN (HYOSCYAMINE SULFATE) TABLET [ALAVEN PHARMACEUTICAL LLC]	1
HYOSCYAMINE	ACTIVE MOIETY	PX44XO846X	LEVSIN (HYOSCYAMINE SULFATE) TABLET [ALAVEN PHARMACEUTICAL LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68220-112	LEVSIN (HYOSCYAMINE SULFATE) TABLET [ALAVEN PHARMACEUTICAL LLC]	4	Current NDC, Legacy NDC, 1 package rows	20241103_32388e18-08de-455c-aad4-9c2264435f0f.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
Levsin	HYOSCYAMINE SULFATE	Viatris Specialty LLC	32388e18-08de-455c-aad4-9c2264435f0f	2025-07-15	Warnings, Adverse reactions	Exact identifier ndc (product): 68220-112

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
1047905	hyoscyamine sulfate 0.125 MG Oral Tablet	PSN	32388e18-08de-455c-aad4-9c2264435f0f	6
1047907	Levsin 0.125 MG Oral Tablet	PSN	32388e18-08de-455c-aad4-9c2264435f0f	6
1047907	hyoscyamine sulfate 0.125 MG Oral Tablet [Levsin]	SBD	32388e18-08de-455c-aad4-9c2264435f0f	6
1047905	hyoscyamine sulfate 0.125 MG Oral Tablet	SCD	32388e18-08de-455c-aad4-9c2264435f0f	6
1047907	Levsin 0.125 MG Oral Tablet	SY	32388e18-08de-455c-aad4-9c2264435f0f	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68220-112-10	68220011210	100 TABLET in 1 BOTTLE (68220-112-10)	100 tablet	1955-06-01	0000-00-00	No	No	Current
68220-112-50	68220011250	500 TABLET in 1 BOTTLE (68220-112-50)	500 tablet	1955-06-01	0000-00-00	No	No	Current