Ranitidine Hydrochloride

Product NDC: 0781-1883
11-digit product format: 007811883
Labeler code: 0781
Product ID: 0781-1883_b913def8-10c9-4651-82dc-a714decc1218
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ranitidine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA074467
Marketing category: ANDA
Marketing start: 1997-08-29
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
111d457e-3138-4512-b0ba-d0cd760c4055	Product name	3	20250225
0426261e-1bb9-b78b-abd2-80da765a7e3e	Product name	2	20240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7	Product name	5	20240320
0ac2f11f-f58d-baf2-71a0-680993b48a61	Product name	2	20231211
855d63c3-b090-4636-8fc7-6d39ad23c44f	Product name	1	20230829
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
bb58f410-04be-65dd-9211-e89ead899698	Product name	6	20230323
0fcbc38a-8b29-3348-1cef-5222ea53484f	Product name	4	20220516
c4e1eedc-aca2-4551-8382-89144ed9d049	Product name	3	20220126
8d368a34-1453-43ea-828d-0dbcd72b8794	Product name	8	20210622
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201
d6bab9d2-edce-a213-4796-226ab15472c3	Product name	6	20200616
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
2487e6ef-d419-42fc-aaf8-7acc805d2370	Product name	2	20170718
2f9d4e5c-e179-490e-8c43-f19e1e0ca228	Product name	1	20160720
e071c814-e5e7-e7ed-ec76-428765d9c66b	Product name	2	20151120
93148e06-b8d7-4e6c-853e-62f807d17fbb	Product name	1	20151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247e	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0781-1883-01	2020-08-19	C162847	48780-1	ab0e2407-2681-f274-e053-dbdaa90a6471	Ranitidine Hydrochloride Capsules Rx Only
0781-1883-05	2020-08-19	C162847	48780-1	ab0e2407-2681-f274-e053-dbdaa90a6471	Ranitidine Hydrochloride Capsules Rx Only
0781-1883-10	2020-08-19	C162847	48780-1	ab0e2407-2681-f274-e053-dbdaa90a6471	Ranitidine Hydrochloride Capsules Rx Only
0781-1883-60	2020-08-19	C162847	48780-1	ab0e2407-2681-f274-e053-dbdaa90a6471	Ranitidine Hydrochloride Capsules Rx Only
0781-1883-01	2020-07-22	C162847	48780-1	ab0e2407-2681-f274-e053-dbdaa90a6471	Ranitidine Hydrochloride Capsules Rx Only
0781-1883-05	2020-07-22	C162847	48780-1	ab0e2407-2681-f274-e053-dbdaa90a6471	Ranitidine Hydrochloride Capsules Rx Only
0781-1883-10	2020-07-22	C162847	48780-1	ab0e2407-2681-f274-e053-dbdaa90a6471	Ranitidine Hydrochloride Capsules Rx Only
0781-1883-60	2020-07-22	C162847	48780-1	ab0e2407-2681-f274-e053-dbdaa90a6471	Ranitidine Hydrochloride Capsules Rx Only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-1883-10	EA - Each	0781-1883	e49cab76-efcd-43e8-9091-65805c64dc7d	1	2012-07-24
0781-1883-13	EA - Each	0781-1883	2b8c1983-7322-49dd-b8cc-70d37a05dd5d	1	2012-07-24
0781-1883-60	EA - Each	0781-1883	e2f0f7c7-ba64-4075-8226-76a5f41e3b9f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAPSAICIN	ACTIVE INGREDIENT	S07O44R1ZM	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
RANITIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	BK76465IHM	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
CAPSAICIN	ACTIVE MOIETY	S07O44R1ZM	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
RANITIDINE	ACTIVE MOIETY	884KT10YB7	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
CETYL ACETATE	INACTIVE INGREDIENT	4Q43814HXS	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
PPG-20 METHYL GLUCOSE ETHER DISTEARATE	INACTIVE INGREDIENT	0057334FAB	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
STEARETH-100	INACTIVE INGREDIENT	4OH5W9UM87	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
RANITIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	BK76465IHM	RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.]	1
RANITIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	BK76465IHM	RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
RANITIDINE	ACTIVE MOIETY	884KT10YB7	RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.]	1
RANITIDINE	ACTIVE MOIETY	884KT10YB7	RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.]	1
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.]	1
HYPROMELLOSE 2910 (3 CPS)	INACTIVE INGREDIENT	0VUT3PMY82	RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.]	1
HYPROMELLOSE 2910 (3 CPS)	INACTIVE INGREDIENT	0VUT3PMY82	RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.]	1
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.]	1
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	RANITIDINE HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BK76465IHM	RANITIDINE HYDROCHLORIDE	66357-59-3	RANITIDINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198555	capsaicin 0.025 % Topical Cream	PSN	1dab5315-5027-57ad-e054-00144ff8d46c	2
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	PSN	1dab5315-5027-57ad-e054-00144ff8d46c	2
198555	capsaicin 0.25 MG/ML Topical Cream	SCD	1dab5315-5027-57ad-e054-00144ff8d46c	2
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	SCD	1dab5315-5027-57ad-e054-00144ff8d46c	2
198555	capsaicin 0.025 % Topical Cream	SY	1dab5315-5027-57ad-e054-00144ff8d46c	2
198191	ranitidine 150 MG Oral Tablet	PSN	9ed8b5a6-4bbe-49dd-901b-1d86e8378bd3	1
198191	ranitidine 150 MG Oral Tablet	PSN	dbc611aa-8fbd-4142-b3e1-82fde917a06a	1
198191	ranitidine 150 MG Oral Tablet	SCD	9ed8b5a6-4bbe-49dd-901b-1d86e8378bd3	1
198191	ranitidine 150 MG Oral Tablet	SCD	dbc611aa-8fbd-4142-b3e1-82fde917a06a	1
198191	ranitidine 150 MG (as ranitidine HCl 168 MG) Oral Tablet	SY	9ed8b5a6-4bbe-49dd-901b-1d86e8378bd3	1
198191	ranitidine 150 MG (as ranitidine HCl 168 MG) Oral Tablet	SY	dbc611aa-8fbd-4142-b3e1-82fde917a06a	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Inflamation Reduction Pack	TMIG, Inc. \| EPM Packaging \| Garcoa, Inc. \| Sandoz Inc. \| Actavis Elizabeth LLC	2015-08-18	HUMAN PRESCRIPTION DRUG LABEL	2
Ranitidine Tablets, USP and Ranitidine Capsules	Keltman Pharmaceuticals Inc. \| Sandhills Packaging	2010-06-03	HUMAN PRESCRIPTION DRUG LABEL	1
Ranitidine Tablets, USP and Ranitidine Capsules	State of Florida DOH Central Pharmacy	2010-04-13	HUMAN PRESCRIPTION DRUG LABEL	1

Ranitidine Hydrochloride

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Related DailyMed Labels#