Ranitidine

Product NDC: 50436-6930
11-digit product format: 504366930
Labeler code: 50436
Product ID: 50436-6930_837d6117-c8be-4a0a-9636-06feb9cd8851
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ranitidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA078542
Marketing category: ANDA
Marketing start: 2008-11-19
Marketing end: 0000-00-00
Substance: RANITIDINE HYDROCHLORIDE
Active strength: 150 mg/1
Pharmacologic classes: Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7f54af34-be54-4c3c-894f-78df6452d747	Product name	3	20190703
ccf8541e-b7dc-e6ba-06c9-15bf143a7850	Product name	5	20190611
05700d9e-ea6f-4aab-b0ed-1488f1d85d7b	Product name	1	20180904
2f9d4e5c-e179-490e-8c43-f19e1e0ca228	Product name	1	20160720

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50436-6930-2	2021-01-29	C162847	48780-1	ba0f9c33-4551-a910-e053-dadaa90a0b85	Ranitidine Tablets USP, 150 mg and 300 mg
50436-6930-3	2021-01-29	C162847	48780-1	ba0f9c33-4551-a910-e053-dadaa90a0b85	Ranitidine Tablets USP, 150 mg and 300 mg
50436-6930-4	2021-01-29	C162847	48780-1	ba0f9c33-4551-a910-e053-dadaa90a0b85	Ranitidine Tablets USP, 150 mg and 300 mg
50436-6930-6	2021-01-29	C162847	48780-1	ba0f9c33-4551-a910-e053-dadaa90a0b85	Ranitidine Tablets USP, 150 mg and 300 mg

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50436-6930-2	Ranitidine	30 in 1 BOTTLE	TABLET, FILM COATED	30	6
50436-6930-3	Ranitidine	90 in 1 BOTTLE	TABLET, FILM COATED	90	6
50436-6930-4	Ranitidine	60 in 1 BOTTLE	TABLET, FILM COATED	60	6
50436-6930-6	Ranitidine	180 in 1 BOTTLE	TABLET, FILM COATED	180	6

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-6930-2	EA - Each	50436-6930	eb37e743-16ad-4da2-a58a-c17245ebb70c	1	2012-07-24
50436-6930-3	EA - Each	50436-6930	41547e86-0f36-478f-b97b-c257212c80cd	1	2014-12-01
50436-6930-4	EA - Each	50436-6930	6cadcfb6-3657-4ad1-a66a-63ff6a781f41	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RANITIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	BK76465IHM	RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]	2
RANITIDINE	ACTIVE MOIETY	884KT10YB7	RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-6930	RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]	6	Legacy NDC, 4 package rows	20190531_1153e9d4-e621-4c08-914a-69f0f8691824.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BK76465IHM	RANITIDINE HYDROCHLORIDE	66357-59-3	RANITIDINE HYDROCHLORIDE
884KT10YB7	RANITIDINE	66357-35-5	Ranitidine

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198191	ranitidine 150 MG Oral Tablet	PSN	1153e9d4-e621-4c08-914a-69f0f8691824	6
198191	ranitidine 150 MG Oral Tablet	SCD	1153e9d4-e621-4c08-914a-69f0f8691824	6
198191	ranitidine 150 MG (as ranitidine HCl 168 MG) Oral Tablet	SY	1153e9d4-e621-4c08-914a-69f0f8691824	6

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-6930-2	50436693002	30 in 1 BOTTLE	Historical
50436-6930-3	50436693003	90 in 1 BOTTLE	Historical
50436-6930-4	50436693004	60 in 1 BOTTLE	Historical
50436-6930-6	50436693006	180 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ranitidine Tablets USP, 150 mg and 300 mg	Unit Dose Services	2019-05-30	HUMAN PRESCRIPTION DRUG LABEL	6