Application 091429

Type: ANDA
Sponsor: PERRIGO R AND D

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
002	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	TABLET;ORAL	EQ 150MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A091429-001	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2011-05-11
A091429-002	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2011-05-11

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`3a93d1ddd44b…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ranitidine Hydrochloride	RANITIDINE HYDROCHLORIDE	Dr. Reddy's Laboratories Limited	7bf94bf7-fa11-70be-9f65-fe26a3db5a63	2018-11-21	Adverse reactions	Name fallback brand name: Ranitidine Hydrochloride generic name: RANITIDINE HYDROCHLORIDE
Acid Reducer	RANITIDINE HYDROCHLORIDE	WinCo Foods, LLC	70bc7062-ab3c-43eb-b524-0d8c6d1a674d	2014-12-10	Warnings	Name fallback generic name: RANITIDINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 108 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0852	Good Sense Acid Reducer	Ranitidine	L. Perrigo Company	ANDA	Current
0113-7852	basic care acid reducer 150	Ranitidine	L. Perrigo Company	ANDA	Current
0113-7852	basic care acid reducer 150	Ranitidine	L. Perrigo Company	ANDA	Current
0113-7950	basic care acid reducer	Ranitidine	L. Perrigo Company	ANDA	Current
0363-0852	wal zan 150	Ranitidine	Walgreen Company	ANDA	Current
0363-0852	wal zan 150	Ranitidine	Walgreen Company	ANDA	Current
0363-0950	wal zan 150	Ranitidine	Walgreen Company	ANDA	Current
0904-6716	Ranitidine	Ranitidine	Major Pharmaceuticals	ANDA	Current
0904-6716	Ranitidine	Ranitidine	Major Pharmaceuticals	ANDA	Current
10202-852	7 Select Acid Reducer	Ranitidine	7-Eleven	ANDA	Current
10202-852	7 Select Acid Reducer	Ranitidine	7-Eleven	ANDA	Current
11673-023	up and up ranitidine	Ranitidine	Target Corporation	ANDA	Current
11673-023	up and up ranitidine	Ranitidine	Target Corporation	ANDA	Current
11673-852	Up and Up Ranitidine	Ranitidine	Target Corporation	ANDA	Current
11673-852	Up and Up Ranitidine	Ranitidine	Target Corporation	ANDA	Current
11673-950	up and up ranitidine 150	Ranitidine	Target Corporation	ANDA	Current
11673-950	up and up ranitidine 150	Ranitidine	Target Corporation	ANDA	Current
11822-0852	Acid Reducer	Ranitidine	Rite Aid Corporation	ANDA	Current
11822-0852	Acid Reducer	Ranitidine	Rite Aid Corporation	ANDA	Current
11822-0950	cool mint acid reducer	Ranitidine	Rite Aid Corporation	ANDA	Current
21130-116	Signature Care Acid Control	Ranitidine	Safeway	ANDA	Current
21130-116	Signature Care Acid Control	Ranitidine	Safeway	ANDA	Current
21130-568	signature care acid control	Ranitidine	Safeway	ANDA	Current
21130-568	signature care acid control	Ranitidine	Safeway	ANDA	Current
30142-600	heartburn relief 150	Ranitidine	Kroger Company	ANDA	Current
30142-600	heartburn relief 150	Ranitidine	Kroger Company	ANDA	Current
30142-891	heartburn relief 150	Ranitidine	Kroger Company	ANDA	Current
36800-852	Topcare Heartburn Relief 150	Ranitidine	Topco Associates LLC	ANDA	Current
36800-852	Topcare Heartburn Relief 150	Ranitidine	Topco Associates LLC	ANDA	Current
36800-950	topcare heartburn relief 150	Ranitidine	Topco Associates LLC	ANDA	Current
36800-950	topcare heartburn relief 150	Ranitidine	Topco Associates LLC	ANDA	Current
37012-852	Acid Reducer	Ranitidine	Shopko Stores Operating Co., LLC	ANDA	Current
37012-950	Acid Reducer	Ranitidine	Shopko Stores Operating Co., LLC	ANDA	Current
37808-507	Acid Reducer	Ranitidine	H E B	ANDA	Current
37808-507	Acid Reducer	Ranitidine	H E B	ANDA	Current
37808-710	Acid Reducer	Ranitidine	H E B	ANDA	Current
41163-852	equaline acid reducer	Ranitidine	Supervalu Inc	ANDA	Current
41163-852	equaline acid reducer	Ranitidine	Supervalu Inc	ANDA	Current
41163-950	equaline heartburn relief	Ranitidine	Supervalu Inc	ANDA	Current
41163-950	equaline heartburn relief	Ranitidine	Supervalu Inc	ANDA	Current
41190-852	ShopRite Acid Reducer	Ranitidine	Wakefern Food Corporation	ANDA	Current
41190-950	ShopRite Acid Reducer	Ranitidine	Wakefern Food Corporation	ANDA	Current
41250-577	Acid Relief	ranitidine	Meijer Distribution Inc	ANDA	Current
41250-577	Acid Relief	ranitidine	Meijer Distribution Inc	ANDA	Current
41250-852	acid reducer	Ranitidine	Meijer Distribution Inc	ANDA	Current
41250-852	acid reducer	Ranitidine	Meijer Distribution Inc	ANDA	Current
41250-891	acid relief	ranitidine	Meijer Distribution Inc	ANDA	Current
41250-891	acid relief	ranitidine	Meijer Distribution Inc	ANDA	Current
41250-891	acid relief	ranitidine	Meijer Distribution Inc	ANDA	Current
41250-891	acid relief	ranitidine	Meijer Distribution Inc	ANDA	Current
41250-950	acid reducer	Ranitidine	Meijer Distribution Inc	ANDA	Current
41250-950	acid reducer	Ranitidine	Meijer Distribution Inc	ANDA	Current
41520-392	CareOne Acid Relief	Ranitidine	American Sales Company	ANDA	Current
41520-392	CareOne Acid Relief	Ranitidine	American Sales Company	ANDA	Current
41520-609	CareOne Acid Relief	Ranitidine	American Sales Company	ANDA	Current
41520-609	CareOne Acid Relief	Ranitidine	American Sales Company	ANDA	Current
41520-852	careone acid reducer	Ranitidine	American Sales Company	ANDA	Current
46122-041	good neighbor pharmacy acid control 150	Ranitidine	Amerisource Bergen	ANDA	Current
46122-041	good neighbor pharmacy acid control 150	Ranitidine	Amerisource Bergen	ANDA	Current
46122-041	good neighbor pharmacy acid control 150	Ranitidine	Amerisource Bergen	ANDA	Current
46122-224	Good Neighbor Pharmacy Acid Control 150	Ranitidine	Amerisource Bergen	ANDA	Current
46122-224	Good Neighbor Pharmacy Acid Control 150	Ranitidine	Amerisource Bergen	ANDA	Current
46122-532	Good Neighbor Pharmacy acid control	Ranitidine	Amerisource Bergen	ANDA	Current
46122-533	good neighbor pharmacy acid control	Ranitidine	Amerisource Bergen	ANDA	Current
46994-852	Being Well Heartburn Relief	Ranitidine	Save-A-Lot Food Stores Ltd	ANDA	Current
49035-608	Equate Ranitidine	Ranitidine	Wal-Mart Stores Inc	ANDA	Current
49035-608	Equate Ranitidine	Ranitidine	Wal-Mart Stores Inc	ANDA	Current
49035-800	Equate Ranitidine Acid Reducer	Ranitidine	Wal-Mart Stores Inc	ANDA	Current
49035-852	equate acid reducer	Ranitidine	Wal-Mart Stores Inc	ANDA	Current
49348-109	Sunmark acid reducer	Ranitidine	Strategic Sourcing Services LLC	ANDA	Current
49348-109	Sunmark acid reducer	Ranitidine	Strategic Sourcing Services LLC	ANDA	Current
49348-109	Sunmark acid reducer	Ranitidine	Mckesson	ANDA	Current
49738-361	smart sense ranitidine	Ranitidine	Kmart Corporation	ANDA	Current
49738-471	Smart Sense Ranitidine	Ranitidine	Kmart Corporation	ANDA	Current
49781-051	Leader Acid Control	Ranitidine	Cardinal Health	ANDA	Current
49781-079	Leader Acid Control	Ranitidine	Cardinal Health	ANDA	Current
50594-852	sound body acid reducer 150	Ranitidine	Big Lots Stores, Inc.	ANDA	Current
50594-852	sound body acid reducer 150	Ranitidine	Big Lots Stores, Inc.	ANDA	Current
55301-852	Exchange Select Acid Reducer	Ranitidine	Army & Air Force Exchange Service	ANDA	Current
55301-852	Exchange Select Acid Reducer	Ranitidine	Army & Air Force Exchange Service	ANDA	Current