Ranitidine

Product NDC: 45865-416
11-digit product format: 458650416
Labeler code: 45865
Product ID: 45865-416_9ab204d5-bc25-a818-e053-2995a90ad0da
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ranitidine
Dosage form: TABLET
Route: ORAL
Labeler: Medsource Pharmaceuticals
Application: ANDA077824
Marketing category: ANDA
Marketing start: 2009-12-16
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	45865-416		I	Inactivated by FDA		2026-08-17
excluded package	package	45865-416	45865-416-60	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-416-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-416-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-416-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-416-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-416-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-416-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-416-60	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-416-60	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-416-60	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077824-001	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13
A077824-002	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB		2006-10-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2006-10-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077824-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077824-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077824-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077824-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077824-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077824-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077824-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077824-002	AB	1	`ea99ee380514…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-416-60	2025-01-30	C162847	48780-1	2cef2736-5c01-d83d-e063-dadaa90ab31f	Ranitidine Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-416-60	Ranitidine	60 in 1 BOTTLE	TABLET	60		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
RANITIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	BK76465IHM	RANITIDINE TABLET [MEDSOURCE PHARMACEUTICALS]	1
RANITIDINE	ACTIVE MOIETY	884KT10YB7	RANITIDINE TABLET [MEDSOURCE PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-416	RANITIDINE TABLET [MEDSOURCE PHARMACEUTICALS]	2	Legacy NDC, 1 package rows	20191228_1d733324-93c6-201c-e054-00144ff88e88.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ranitidine	RANITIDINE	Amneal Pharmaceuticals of New York LLC	b38a3332-5c54-453f-aeb7-070f830955c2	2026-05-01	Adverse reactions	Exact identifier application applno (ANDA): 077824 application number: ANDA077824

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198191	ranitidine 150 MG Oral Tablet	PSN	1d733324-93c6-201c-e054-00144ff88e88	2
198191	ranitidine 150 MG Oral Tablet	SCD	1d733324-93c6-201c-e054-00144ff88e88	2
198191	ranitidine 150 MG (as ranitidine HCl 168 MG) Oral Tablet	SY	1d733324-93c6-201c-e054-00144ff88e88	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-416-60	45865041660	60 TABLET in 1 BOTTLE (45865-416-60)	60 tablet	2015-08-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ranitidine Tablets, USP Rx Only	Medsource Pharmaceuticals	2019-12-27	HUMAN PRESCRIPTION DRUG LABEL	2