Ranitidine

Product NDC: 63868-482
11-digit product format: 638680482
Labeler code: 63868
Product ID: 63868-482_0a6cabbc-6f8a-6095-3696-0b0596c007ec
Type: HUMAN OTC DRUG
Nonproprietary name: Ranitidine
Dosage form: TABLET
Route: ORAL
Labeler: Chain Drug Marketing Association
Application: ANDA075294
Marketing category: ANDA
Marketing start: 2018-07-01
Marketing end: 0000-00-00
Substance: RANITIDINE HYDROCHLORIDE
Active strength: 75 mg/1
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63868-482		D	Discontinued by firm	2026-08-17
excluded package	package	63868-482	63868-482-30	D	Discontinued by firm	2026-08-17
excluded package	package	63868-482	63868-482-60	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 · 33 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		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63868-482-60	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63868-482-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63868-482-60	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63868-482-30	D	Discontinued by firm	`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	63868-482-60	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63868-482-30	D	Discontinued by firm	`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	63868-482-60	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63868-482-30	D	Discontinued by firm	`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	63868-482-60	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63868-482-30	D	Discontinued by firm	`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	63868-482-60	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63868-482-30	D	Discontinued by firm	`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	63868-482-60	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63868-482-30	D	Discontinued by firm	`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	63868-482-60	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63868-482-30	D	Discontinued by firm	`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	63868-482-60	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63868-482-30	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63868-482-60	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63868-482-30	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63868-482-60	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63868-482-30	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63868-482-60	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63868-482-30	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075294-001	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL			2000-03-28

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075294-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2000-03-28	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63868-482-30	2025-07-24	Drug Facts
63868-482-60	2025-07-24	Drug Facts
63868-482-30	2025-01-30	Drug Facts
63868-482-60	2025-01-30	Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-482	RANITIDINE TABLET [CHAIN DRUG MARKETING ASSOCIATION]	3	Legacy NDC	20231103_4718e191-637c-213d-89d3-25b72e499d4a.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	Dr. Reddy's Laboratories Limited	12a38e29-130c-6d41-1753-acccb0b41efe	2025-05-23	Warnings	Exact identifier application applno (ANDA): 075294 application number: ANDA075294

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-482-30	63868048230	1 BOTTLE in 1 CARTON (63868-482-30) > 30 TABLET in 1 BOTTLE	1 bottle	2018-07-01	0000-00-00	No	No	Current
63868-482-60	63868048260	1 BOTTLE in 1 CARTON (63868-482-60) > 60 TABLET in 1 BOTTLE	1 bottle	2018-07-01	0000-00-00	No	No	Current