Ranitidine

Product NDC: 71610-378
11-digit product format: 716100378
Labeler code: 71610
Product ID: 71610-378_01b4ddb6-9dd0-4fef-b85a-667ed83d5ca9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ranitidine
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA205512
Marketing category: ANDA
Marketing start: 2016-08-22
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71610-378		I	Inactivated by FDA	2026-10-05
excluded package	package	71610-378	71610-378-30	I	Inactivated by FDA	2026-10-05
excluded package	package	71610-378	71610-378-60	I	Inactivated by FDA	2026-10-05

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 · 45 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	71610-378-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-378-30	`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	71610-378-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-378-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71610-378-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71610-378-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71610-378-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71610-378-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71610-378-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71610-378-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71610-378-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71610-378-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71610-378-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71610-378-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71610-378-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71610-378-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71610-378-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71610-378-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71610-378-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71610-378-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71610-378-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71610-378-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71610-378-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71610-378-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71610-378-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71610-378-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71610-378-60	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71610-378-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71610-378-60	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71610-378-30	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A205512-001	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2016-08-22
A205512-002	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2016-08-22

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 · 86 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
2026-09-14 22:38:34	2026-08	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2016-08-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2016-08-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205512-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2016-08-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205512-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2016-08-22	`74a2ff9319b5…`

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	A205512-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205512-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A205512-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205512-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205512-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205512-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205512-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205512-002	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
71610-378-30	2023-01-30	C162847	48780-1	f386c64a-3054-0266-e053-dadaa90a7c1a	RANITIDINE
71610-378-60	2023-01-30	C162847	48780-1	f386c64a-3054-0266-e053-dadaa90a7c1a	RANITIDINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71610-378-30	RanitidineImmediate release	30 in 1 BOTTLE	TABLET	30		1
71610-378-60	RanitidineImmediate release	90 in 1 BOTTLE	TABLET	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-378-30	EA - Each	71610-378	8a137468-79fe-4bfd-883e-a8cf2451e50a	1	2020-03-10
71610-378-60	EA - Each	71610-378	c0dd225d-04fc-4c38-8084-8e8be6a76198	1	2020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-378	RANITIDINE IMMEDIATE RELEASE (RANITIDINE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 2 package rows	20200212_a897069a-0af0-499d-983f-afee0e9792fd.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	a897069a-0af0-499d-983f-afee0e9792fd	1
198191	ranitidine 150 MG Oral Tablet	SCD	a897069a-0af0-499d-983f-afee0e9792fd	1
198191	ranitidine 150 MG (as ranitidine HCl 168 MG) Oral Tablet	SY	a897069a-0af0-499d-983f-afee0e9792fd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-378-30	71610037830	30 TABLET in 1 BOTTLE (71610-378-30)	30 tablet	2019-12-26	0000-00-00	No	No	Current
71610-378-60	71610037860	90 TABLET in 1 BOTTLE (71610-378-60)	90 tablet	2019-12-26	0000-00-00	No	No	Current