Application 078192

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	TABLET;ORAL	EQ 150MG BASE	No	No

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
A078192-001	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2007-08-31

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	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078192-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2007-08-31	`e64feba35796…`

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	00df8a42-296f-80dd-98af-ee8b30eb38cc	2025-05-23	Warnings	Exact identifier application applno (ANDA): 078192 application number: ANDA078192 ndc (product): 55111-404

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0010	Wal-Zan	Ranitidine Hydrochloride Tablets 150mg	Walgreens Company	ANDA	Current
11673-849	Ranitidine	Ranitidine	Target Corporation	ANDA	Current
21130-404	Acid Reducer 150	Ranitidine Hydrochloride Tablets 150mg	Safeway Inc	ANDA	Current
30142-505	Heratburn Relief	Ranitidine	The Kroger Co.	ANDA	Current
43598-808	Ranitidine	Ranitidine	Dr. Reddy's Laboratories Inc.	ANDA	Current
49035-404	Ranitidine 150	Ranitidine Hydrochloride Tablets 150mg	Walmart Stores Inc.	ANDA	Current
53943-741	HEARTBURN RELIEVER 150	Ranitidine	Discount Drug Mart	ANDA	Current
53943-741	HEARTBURN RELIEVER 150	Ranitidine	Discount Drug Mart	ANDA	Current
53943-741	HEARTBURN RELIEVER 150	Ranitidine	Discount Drug Mart	ANDA	Current
55111-404	Ranitidine	Ranitidine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-404	Ranitidine	Ranitidine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-404	Ranitidine	Ranitidine	Dr. Reddy's Laboratories Limited	ANDA	Current
57896-717	ACID REDUCER	Ranitidine	GERI-CARE PHARMACEUTICAL CORP	ANDA	Current
57896-717	ACID REDUCER	Ranitidine	GERI-CARE PHARMACEUTICAL CORP	ANDA	Current
63868-480	Ranitidine	Ranitidine	Chain Drug Marketing Association	ANDA	Current
68196-985	Ranitidine	Ranitidine	Sam's West Inc	ANDA	Current
68998-375	Ranitidine 150	Ranitidine HCl Tablets 150mg	Marc Glassman, Inc.	ANDA	Current
68998-397	Ranitidine 150	Ranitidine HCl Tablets 150mg	Marc Glassman, Inc.	ANDA	Current
69168-375	Ranitidine 150	Ranitidine Hydrochloride Tablets 150mg	Allegiant Health	ANDA	Current
69168-375	Ranitidine 150	Ranitidine Hydrochloride Tablets 150mg	Allegiant Health	ANDA	Current
69168-389	Ranitidine 150	Ranitidine Hydrochloride Tablets 150mg	Allegiant Health	ANDA	Current
69168-902	Ranitidine 150	Ranitidine HCl Tablets 150mg	Allegiant Health	ANDA	Current
69842-869	Acid Reducer	Ranitidine	CVS HEALTH CORP	ANDA	Current
71713-203	Ranitidine	Ranitidine	Thirty Madison Inc	ANDA	Current
71713-203	Ranitidine	Ranitidine	Thirty Madison Inc	ANDA	Current