Ranitidine

Product NDC: 10544-516
11-digit product format: 105440516
Labeler code: 10544
Product ID: 10544-516_11f47301-cec6-1516-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ranitidine
Dosage form: TABLET
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA077824
Marketing category: ANDA
Marketing start: 2010-10-21
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: 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
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
10544-516-20	2020-01-31	C162847	48780-1	9d75b9d0-b305-f424-e053-dadaa90a57ce	Ranitidine Tablets, USP Rx Only

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-516-20	Ranitidine	20 in 1 BOTTLE	TABLET	20		1

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-516-20	EA - Each	10544-516	66d1fc57-768d-45e4-83e7-124bfe5d29bc	1	2015-10-02

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
RANITIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	BK76465IHM	RANITIDINE TABLET [BLENHEIM PHARMACAL, INC.]	1
RANITIDINE	ACTIVE MOIETY	884KT10YB7	RANITIDINE TABLET [BLENHEIM PHARMACAL, INC.]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-516	RANITIDINE TABLET [BLENHEIM PHARMACAL, INC.]	1	Legacy NDC, 1 package rows	20150323_11f47301-cec7-1516-e054-00144ff88e88.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	11f47301-cec7-1516-e054-00144ff88e88	1
198191	ranitidine 150 MG Oral Tablet	SCD	11f47301-cec7-1516-e054-00144ff88e88	1
198191	ranitidine 150 MG (as ranitidine HCl 168 MG) Oral Tablet	SY	11f47301-cec7-1516-e054-00144ff88e88	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-516-20	10544051620	20 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ranitidine Tablets, USP Rx Only	Blenheim Pharmacal, Inc.	2015-03-23	HUMAN PRESCRIPTION DRUG LABEL	1