Ranitidine

Product NDC: 71335-1327
11-digit product format: 713351327
Labeler code: 71335
Product ID: 71335-1327_bafb1e84-af62-42d7-9e28-61b0a719fcc5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ranitidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
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: 2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71335-1327		D	Discontinued by firm	2026-08-17
excluded package	package	71335-1327	71335-1327-1	D	Discontinued by firm	2026-08-17
excluded package	package	71335-1327	71335-1327-2	D	Discontinued by firm	2026-08-17
excluded package	package	71335-1327	71335-1327-3	D	Discontinued by firm	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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1327-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1327-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1327-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1327-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1327-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1327-2	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A078542-001	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2008-11-19
A078542-002	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2008-11-19

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2008-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2008-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2008-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2008-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2008-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2008-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A078542-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078542-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078542-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078542-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078542-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078542-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078542-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078542-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078542-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078542-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078542-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078542-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078542-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078542-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078542-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078542-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078542-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078542-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078542-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078542-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078542-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078542-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078542-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078542-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078542-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078542-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078542-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078542-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078542-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078542-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078542-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078542-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078542-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078542-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078542-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078542-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078542-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078542-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078542-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078542-002	AB	1	`5aa47cf7b7d7…`

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-1327-1	Ranitidine	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
71335-1327-2	Ranitidine	60 in 1 BOTTLE	TABLET, FILM COATED	60	2
71335-1327-3	Ranitidine	90 in 1 BOTTLE	TABLET, FILM COATED	90	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1327	RANITIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	2	Legacy NDC, 3 package rows	20200708_e24b34ec-d779-4c99-a9e9-0a3bdee39f0c.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198191	ranitidine 150 MG Oral Tablet	PSN	e24b34ec-d779-4c99-a9e9-0a3bdee39f0c	2
198193	ranitidine 300 MG Oral Tablet	PSN	e24b34ec-d779-4c99-a9e9-0a3bdee39f0c	2
198191	ranitidine 150 MG Oral Tablet	SCD	e24b34ec-d779-4c99-a9e9-0a3bdee39f0c	2
198193	ranitidine 300 MG Oral Tablet	SCD	e24b34ec-d779-4c99-a9e9-0a3bdee39f0c	2
198191	ranitidine 150 MG (as ranitidine HCl 168 MG) Oral Tablet	SY	e24b34ec-d779-4c99-a9e9-0a3bdee39f0c	2
198193	ranitidine 300 MG (as ranitidine HCl 336 MG) Oral Tablet	SY	e24b34ec-d779-4c99-a9e9-0a3bdee39f0c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1327-1	71335132701	30 TABLET, FILM COATED in 1 BOTTLE (71335-1327-1)	2008-11-19	0000-00-00	No	No	Current
71335-1327-2	71335132702	60 TABLET, FILM COATED in 1 BOTTLE (71335-1327-2)	2008-11-19	0000-00-00	No	No	Current
71335-1327-3	71335132703	90 TABLET, FILM COATED in 1 BOTTLE (71335-1327-3)	2008-11-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ranitidine Tablets USP, 150 mg and 300 mg	Bryant Ranch Prepack	2020-07-07	HUMAN PRESCRIPTION DRUG LABEL	2