Hyoscyamine Sulfate

Product NDC: 43199-011
11-digit product format: 431990011
Labeler code: 43199
Product ID: 43199-011_b654a059-ca15-4c92-96d1-5ca24e5232df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hyoscyamine Sulfate
Dosage form: TABLET
Route: ORAL; SUBLINGUAL
Labeler: County Line Pharmaceuticals, LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2009-09-21
Marketing end: 2023-11-01
Substance: HYOSCYAMINE SULFATE
Active strength: 0 mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43199-011-01	EA - Each	43199-011	24c49f88-6cc4-443e-910f-94f31a27face	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
HYOSCYAMINE SULFATE	ACTIVE INGREDIENT	F2R8V82B84	HYOSCYAMINE SULFATE TABLET [CARILION MATERIALS MANAGEMENT]	2
HYOSCYAMINE	ACTIVE MOIETY	PX44XO846X	HYOSCYAMINE SULFATE TABLET [CARILION MATERIALS MANAGEMENT]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYOSCYAMINE SULFATE TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYOSCYAMINE SULFATE TABLET [CARILION MATERIALS MANAGEMENT]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	HYOSCYAMINE SULFATE TABLET [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYOSCYAMINE SULFATE TABLET [CARILION MATERIALS MANAGEMENT]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	HYOSCYAMINE SULFATE TABLET [CARILION MATERIALS MANAGEMENT]	2
HYOSCYAMINE SULFATE	ACTIVE INGREDIENT	F2R8V82B84	HYOSCYAMINE SULFATE TABLET [REBEL DISTRIBUTORS CORP]	1
HYOSCYAMINE	ACTIVE MOIETY	PX44XO846X	HYOSCYAMINE SULFATE TABLET [REBEL DISTRIBUTORS CORP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYOSCYAMINE SULFATE TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYOSCYAMINE SULFATE TABLET [REBEL DISTRIBUTORS CORP]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	HYOSCYAMINE SULFATE TABLET [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYOSCYAMINE SULFATE TABLET [REBEL DISTRIBUTORS CORP]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	HYOSCYAMINE SULFATE TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1046982	hyoscyamine sulfate 0.125 MG Sublingual Tablet	PSN	fbfcc2d7-39a8-415b-ac17-73750cc9f8cf	2
1046982	hyoscyamine sulfate 0.125 MG Sublingual Tablet	SCD	fbfcc2d7-39a8-415b-ac17-73750cc9f8cf	2
1046982	hyoscyamine sulfate SL 0.125 Disintegrating Sublingual Tablet	SY	fbfcc2d7-39a8-415b-ac17-73750cc9f8cf	2
1046982	hyoscyamine sulfate 0.125 MG Sublingual Tablet	PSN	843d2e6f-9110-4b0d-894f-63b1b206b5ec	1
1046982	hyoscyamine sulfate 0.125 MG Sublingual Tablet	SCD	843d2e6f-9110-4b0d-894f-63b1b206b5ec	1
1046982	hyoscyamine sulfate SL 0.125 Disintegrating Sublingual Tablet	SY	843d2e6f-9110-4b0d-894f-63b1b206b5ec	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43199-011-01	43199001101	100 TABLET in 1 BOTTLE (43199-011-01)	100 tablet	2009-09-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg PI-9322 Rev 04/09 Rx Only	Rebel Distributors Corp	2011-07-12	HUMAN PRESCRIPTION DRUG LABEL	1
Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg PI-9322 Rev 04/09 Rx Only	Carilion Materials Management	2010-01-12	HUMAN PRESCRIPTION DRUG LABEL	2