Ranitidine

Product NDC: 21695-110
11-digit product format: 216950110
Labeler code: 21695
Product ID: 21695-110_dcee67ac-e58c-4050-ad16-f8253a17036b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ranitidine
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors
Application: ANDA077824
Marketing category: ANDA
Marketing start: 2009-12-17
Marketing end: 0000-00-00
Substance: RANITIDINE HYDROCHLORIDE
Active strength: 300 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

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	21695-110		I	Inactivated by FDA	2026-08-17
excluded package	package	21695-110	21695-110-15	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-110	21695-110-30	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-110	21695-110-60	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 2 · 88 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	21695-110-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-110-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-110-30	`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	21695-110-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-110-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-110-30	`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	21695-110-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-110-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-110-30	`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	21695-110-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-110-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-110-30	`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	21695-110-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-110-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-110-30	`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	21695-110-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-110-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-110-30	`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	21695-110-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-110-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-110-30	`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	21695-110-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-110-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-110-30	`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	21695-110-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-110-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-110-30	`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	21695-110-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-110-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-110-30	`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	21695-110-15	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-110-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-110-30	`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	21695-110-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-110-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-110-30	`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	21695-110-15	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-110-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-110-30	`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	21695-110-15	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-110-60	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-110-30	`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	21695-110-15	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-110-60	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-110-30	`1332a3947898…`	`d4bfe170f9cd…`

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
21695-110-15	2019-09-24	C162847	48780-1	934fe258-4b33-48b1-e053-8cdaa90a720a	Ranitidine Tablets, USP
21695-110-30	2019-09-24	C162847	48780-1	934fe258-4b33-48b1-e053-8cdaa90a720a	Ranitidine Tablets, USP
21695-110-60	2019-09-24	C162847	48780-1	934fe258-4b33-48b1-e053-8cdaa90a720a	Ranitidine Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-110-15	Ranitidine	15 in 1 BOTTLE	TABLET	15	1
21695-110-30	Ranitidine	30 in 1 BOTTLE	TABLET	30	1
21695-110-60	Ranitidine	60 in 1 BOTTLE	TABLET	60	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-110-15	EA - Each	21695-110	568fa570-a79e-44c7-8e67-a999e9374b74	1	2012-07-24
21695-110-30	EA - Each	21695-110	1eb39e09-155e-4bca-bdb4-d3de698d013f	1	2012-07-24
21695-110-60	EA - Each	21695-110	7a2569c7-87ac-46e6-993c-8e2f810fd7fe	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
RANITIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	BK76465IHM	RANITIDINE (RANITIDINE) TABLET [REBEL DISTRIBUTORS]	1
RANITIDINE	ACTIVE MOIETY	884KT10YB7	RANITIDINE (RANITIDINE) TABLET [REBEL DISTRIBUTORS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-110	RANITIDINE (RANITIDINE) TABLET [REBEL DISTRIBUTORS]	1	Legacy NDC, 3 package rows	20100216_a9fef8f6-b823-4b8a-84b8-2b916374adb5.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	a9fef8f6-b823-4b8a-84b8-2b916374adb5	1
198193	ranitidine 300 MG Oral Tablet	PSN	a9fef8f6-b823-4b8a-84b8-2b916374adb5	1
198191	ranitidine 150 MG Oral Tablet	SCD	a9fef8f6-b823-4b8a-84b8-2b916374adb5	1
198193	ranitidine 300 MG Oral Tablet	SCD	a9fef8f6-b823-4b8a-84b8-2b916374adb5	1
198191	ranitidine 150 MG (as ranitidine HCl 168 MG) Oral Tablet	SY	a9fef8f6-b823-4b8a-84b8-2b916374adb5	1
198193	ranitidine 300 MG (as ranitidine HCl 336 MG) Oral Tablet	SY	a9fef8f6-b823-4b8a-84b8-2b916374adb5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-110-15	21695011015	15 in 1 BOTTLE	Historical
21695-110-30	21695011030	30 in 1 BOTTLE	Historical
21695-110-60	21695011060	60 in 1 BOTTLE	Historical