Levsin

Product NDC: 68220-113
11-digit product format: 682200113
Labeler code: 68220
Product ID: 68220-113_18c4b7b1-8d9a-46c2-aa14-37820d5d6496
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hyoscyamine sulfate
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Viatris Specialty LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2008-12-01
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	68220-113-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68220-113-50	`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	68220-113-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68220-113-50	`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	68220-113-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68220-113-50	`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	68220-113-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68220-113-50	`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	68220-113-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68220-113-50	`1332a3947898…`	`d4bfe170f9cd…`

Additional Listing Data#

Finished product: Yes
Brand name base: Levsin
Brand name suffix: SL
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
1046982	Internal RxNorm lookup
1047908	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
f38ece41-b890-11e2-9e96-0800200c9a66	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68220-113-10	2024-11-01	Levsin ® /SL tablets (hyoscyamine sulfate tablets USP) Rx Only 201092-01 Rev. 07/2025
68220-113-50	2024-11-01	Levsin ® /SL tablets (hyoscyamine sulfate tablets USP) Rx Only 201092-01 Rev. 07/2025
68220-113-10	2024-01-30	Levsin ® /SL tablets (hyoscyamine sulfate tablets USP) Rx Only 201092-01 Rev. 07/2025
68220-113-50	2024-01-30	Levsin ® /SL tablets (hyoscyamine sulfate tablets USP) Rx Only 201092-01 Rev. 07/2025

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68220-113-10	LevsinSL	100 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68220-113-10	EA - Each	68220-113	31042fe5-c0f8-41d0-8d8f-127237cecd0f	1	2013-06-04
68220-113-50	EA - Each	68220-113	7ae0fdaf-0379-4c52-a788-40fa59cb508a	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 SL (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [ALAVEN PHARMACEUTICAL LLC]	1
HYOSCYAMINE	ACTIVE MOIETY	PX44XO846X	LEVSIN SL (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [ALAVEN PHARMACEUTICAL LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68220-113	LEVSIN SL (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [ALAVEN PHARMACEUTICAL LLC]	4	Current NDC, Legacy NDC, 1 package rows	20241103_f38ece41-b890-11e2-9e96-0800200c9a66.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 SL	HYOSCYAMINE SULFATE	Viatris Specialty LLC	f38ece41-b890-11e2-9e96-0800200c9a66	2013-05-14	Warnings, Adverse reactions	Exact identifier ndc (product): 68220-113

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
1046982	hyoscyamine sulfate 0.125 MG Sublingual Tablet	PSN	f38ece41-b890-11e2-9e96-0800200c9a66	6
1047908	Levsin SL 0.125 MG Sublingual Tablet	PSN	f38ece41-b890-11e2-9e96-0800200c9a66	6
1047908	hyoscyamine sulfate 0.125 MG Sublingual Tablet [Levsin]	SBD	f38ece41-b890-11e2-9e96-0800200c9a66	6
1046982	hyoscyamine sulfate 0.125 MG Sublingual Tablet	SCD	f38ece41-b890-11e2-9e96-0800200c9a66	6
1046982	hyoscyamine sulfate SL 0.125 Disintegrating Sublingual Tablet	SY	f38ece41-b890-11e2-9e96-0800200c9a66	6
1047908	Levsin 0.125 MG Sublingual Tablet	SY	f38ece41-b890-11e2-9e96-0800200c9a66	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68220-113-10	68220011310	100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68220-113-10)	2008-12-01	0000-00-00	No	No	Current
68220-113-50	68220011350	500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68220-113-50)	2008-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levsin ® /SL tablets (hyoscyamine sulfate tablets USP) Rx Only 201092-01 Rev. 07/2025	Viatris Specialty LLC	2013-05-14	HUMAN PRESCRIPTION DRUG LABEL	6