Ranitidine

Product NDC: 50436-6942
11-digit product format: 504366942
Labeler code: 50436
Product ID: 50436-6942_1beb5243-839a-4ca9-9ab5-5931a22146c0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ranitidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA078542
Marketing category: ANDA
Marketing start: 2008-11-19
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: 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50436-6942		I	Inactivated by FDA	2026-08-17
excluded package	package	50436-6942	50436-6942-1	I	Inactivated by FDA	2026-08-17
excluded package	package	50436-6942	50436-6942-3	D	Discontinued by firm	2026-08-17
excluded package	package	50436-6942	50436-6942-4	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 2 · 62 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	50436-6942-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-6942-4	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-6942-3	D	Discontinued by firm	`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	50436-6942-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-6942-4	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-6942-3	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	50436-6942-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-6942-4	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-6942-3	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	50436-6942-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-6942-4	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-6942-3	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	50436-6942-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-6942-4	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-6942-3	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	50436-6942-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-6942-4	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-6942-3	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-6942-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-6942-4	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-6942-3	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-6942-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-6942-4	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-6942-3	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-6942-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-6942-4	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-6942-3	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-6942-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-6942-4	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-6942-3	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50436-6942-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50436-6942-4	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50436-6942-3	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50436-6942-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50436-6942-4	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50436-6942-3	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50436-6942-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50436-6942-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50436-6942-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50436-6942-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50436-6942-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50436-6942-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50436-6942-1	2021-01-29	C162847	48780-1	ba0f9c33-454e-a910-e053-dadaa90a0b85	Ranitidine Tablets USP, 150 mg and 300 mg
50436-6942-3	2021-01-29	C162847	48780-1	ba0f9c33-454e-a910-e053-dadaa90a0b85	Ranitidine Tablets USP, 150 mg and 300 mg
50436-6942-4	2021-01-29	C162847	48780-1	ba0f9c33-454e-a910-e053-dadaa90a0b85	Ranitidine Tablets USP, 150 mg and 300 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50436-6942-1	Ranitidine	30 in 1 BOTTLE	TABLET, FILM COATED	30	12
50436-6942-3	Ranitidine	90 in 1 BOTTLE	TABLET, FILM COATED	90	12
50436-6942-4	Ranitidine	60 in 1 BOTTLE	TABLET, FILM COATED	60	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-6942-1	EA - Each	50436-6942	8d1dfe35-7c0a-4885-96ed-6aed06244ecf	1	2014-11-05
50436-6942-3	EA - Each	50436-6942	bed19b42-350c-40f4-9dff-5c441271b9a6	1	2014-12-01
50436-6942-4	EA - Each	50436-6942	587dc141-b4c6-4f21-9ccd-3247ca44254c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RANITIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	BK76465IHM	RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]	5
RANITIDINE	ACTIVE MOIETY	884KT10YB7	RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]	5
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-6942	RANITIDINE TABLET, FILM COATED [UNIT DOSE SERVICES]	12	Legacy NDC, 3 package rows	20190531_0edf8afb-4af8-4dc9-8d9d-7f233f442736.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
198193	ranitidine 300 MG Oral Tablet	PSN	0edf8afb-4af8-4dc9-8d9d-7f233f442736	12
198193	ranitidine 300 MG Oral Tablet	SCD	0edf8afb-4af8-4dc9-8d9d-7f233f442736	12
198193	ranitidine 300 MG (as ranitidine HCl 336 MG) Oral Tablet	SY	0edf8afb-4af8-4dc9-8d9d-7f233f442736	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-6942-1	50436694201	30 in 1 BOTTLE	Historical
50436-6942-3	50436694203	90 in 1 BOTTLE	Historical
50436-6942-4	50436694204	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ranitidine Tablets USP, 150 mg and 300 mg	Unit Dose Services	2019-05-30	HUMAN PRESCRIPTION DRUG LABEL	12