Lorazepam

Product NDC: 33358-221
11-digit product format: 333580221
Labeler code: 33358
Product ID: 33358-221_600dca46-0151-4959-9891-9a0e54d08a15
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lorazepam
Dosage form: TABLET
Route: ORAL
Labeler: RxChange Co.
Application: ANDA076045
Marketing category: ANDA
Marketing start: 2014-11-12
Marketing end: 0000-00-00
Substance: LORAZEPAM
Active strength: 2 mg/1
Pharmacologic classes: Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a759f740-8682-4896-9194-8b6c103c9aee	Product name	3	20250716
b7badb1c-6d3f-4f95-a4ca-ce69992e58a1	Product name	1	20220308
5d98a0ba-a64b-d9b2-e6ec-87edbb57a285	Product name	2	20180320
ac8efea8-f412-295f-00ce-b095e5cbc115	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
33358-221-30	2020-01-31	C162847	48780-1	9d75b9d1-165f-f424-e053-dadaa90a57ce	LORAZEPAM TABLETS, USP C-IV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
33358-221-30	Lorazepam	30 in 1 BOTTLE	TABLET	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33358-221-30	EA - Each	33358-221	60ffc4a0-a1c2-46a9-a994-170e167053e9	1	2014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
LORAZEPAM	ACTIVE INGREDIENT	O26FZP769L	LORAZEPAM TABLET [RXCHANGE CO.]	1
LORAZEPAM	ACTIVE MOIETY	O26FZP769L	LORAZEPAM TABLET [RXCHANGE CO.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LORAZEPAM TABLET [RXCHANGE CO.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LORAZEPAM TABLET [RXCHANGE CO.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LORAZEPAM TABLET [RXCHANGE CO.]	1
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	LORAZEPAM TABLET [RXCHANGE CO.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33358-221	LORAZEPAM TABLET [RXCHANGE CO.]	1	Legacy NDC, 1 package rows	20141114_388f25e3-3d94-4f83-b66b-cb9e7518db0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197902	LORazepam 2 MG Oral Tablet	PSN	388f25e3-3d94-4f83-b66b-cb9e7518db0a	1
197902	lorazepam 2 MG Oral Tablet	SCD	388f25e3-3d94-4f83-b66b-cb9e7518db0a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33358-221-30	33358022130	30 in 1 BOTTLE	Historical