Application 077824

Type: ANDA
Sponsor: AMNEAL PHARMS NY

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 300MG 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
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 2 of 3 · 88 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
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…`
2021-12-28 21:50 UTC	2021-12	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB		2006-10-13	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2006-10-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB		2006-10-13	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2006-10-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB		2006-10-13	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	RS	2006-10-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077824-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2006-10-13	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077824-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2006-10-13	`3a93d1ddd44b…`

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…`

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 ndc (product): 53746-253 ndc (product): 53746-254

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 · 101 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0440-8300	Ranitidine	Ranitidine	Liberty Pharmaceuticals, Inc.	ANDA	Current
0440-8305	Ranitidine	Ranitidine	Liberty Pharmaceuticals, Inc.	ANDA	Current
10544-056	Ranitidine	Ranitidine	Blenheim Pharmacal, Inc.	ANDA	Current
10544-516	Ranitidine	Ranitidine	Blenheim Pharmacal, Inc.	ANDA	Current
21695-109	Ranitidine	Ranitidine	Rebel Distributors	ANDA	Current
21695-110	Ranitidine	Ranitidine	Rebel Distributors	ANDA	Current
33261-099	Ranitidine	Ranitidine	Aidarex Pharmaceuticals LLC	ANDA	Current
33261-202	Ranitidine	Ranitidine	Aidarex Pharmaceuticals LLC	ANDA	Current
33358-316	Ranitidine	Ranitidine	RxChange Co.	ANDA	Current
35356-670	Ranitidine	Ranitidine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-809	Ranitidine	Ranitidine	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
42291-724	Ranitidine	Ranitidine	AvKARE, Inc.	ANDA	Current
42291-724	Ranitidine	Ranitidine	AvKARE, Inc.	ANDA	Current
42291-724	Ranitidine	Ranitidine	AvKARE	ANDA	Current
42291-725	Ranitidine	Ranitidine	AvKARE, Inc.	ANDA	Current
42291-725	Ranitidine	Ranitidine	AvKARE, Inc.	ANDA	Current
42708-049	Ranitidine	Ranitidine	QPharma Inc	ANDA	Current
42708-118	Ranitidine	Ranitidine	QPharma Inc	ANDA	Current
42708-118	Ranitidine	Ranitidine	QPharma Inc	ANDA	Current
43063-087	Ranitidine	Ranitidine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-087	Ranitidine	Ranitidine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-844	Ranitidine	Ranitidine	PD-Rx Pharmaceuticals, In	ANDA	Current
43063-844	Ranitidine	Ranitidine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43353-445	Ranitidine	Ranitidine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-967	Ranitidine	Ranitidine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-967	Ranitidine	Ranitidine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-971	Ranitidine	Ranitidine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-971	Ranitidine	Ranitidine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
45865-416	Ranitidine	Ranitidine	Medsource Pharmaceuticals	ANDA	Current
45865-416	Ranitidine	Ranitidine	Medsource Pharmaceuticals	ANDA	Current
50090-0604	Ranitidine	Ranitidine	A-S Medication Solutions	ANDA	Current
50090-0605	Ranitidine	Ranitidine	A-S Medication Solutions	ANDA	Current
50090-0606	Ranitidine	Ranitidine	A-S Medication Solutions	ANDA	Current
50436-0253	Ranitidine	Ranitidine	Unit Dose Services	ANDA	Current
50436-0253	Ranitidine	Ranitidine	Unit Dose Services	ANDA	Current
51655-681	RANITIDINE	ranitidine hydrochloride	Northwind Pharmaceuticals, LLC	ANDA	Current
53217-343	Ranitidine	Ranitidine	Aidarex Pharmaceuticals LLC	ANDA	Current
53746-253	Ranitidine	Ranitidine	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-253	Ranitidine	Ranitidine	Amneal Pharmaceuticals of New York, LLC	ANDA	Current
53746-253	Ranitidine	Ranitidine	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-253	Ranitidine	Ranitidine	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-254	Ranitidine	Ranitidine	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-254	Ranitidine	Ranitidine	Amneal Pharmaceuticals of New York, LLC	ANDA	Current
53746-254	Ranitidine	Ranitidine	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-254	Ranitidine	Ranitidine	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53808-0775	Ranitidine	Ranitidine	State of Florida DOH Central Pharmacy	ANDA	Current
55289-319	Ranitidine	Ranitidine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-319	Ranitidine	Ranitidine	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
60687-322	Ranitidine	Ranitidine	American Health Packaging	ANDA	Current
60687-322	Ranitidine	Ranitidine	American Health Packaging	ANDA	Current
60687-322	Ranitidine	Ranitidine	American Health Packaging	ANDA	Current
60760-026	RANITIDINE	RANITIDINE	St Marys Medical Park Pharmacy	ANDA	Current
61919-199	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	Direct Rx	ANDA	Current
61919-199	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	Direct Rx	ANDA	Current
63187-686	Ranitidine	Ranitidine	Proficient Rx LP	ANDA	Current
63187-686	Ranitidine	Ranitidine	Proficient Rx LP	ANDA	Current
63629-1671	Ranitidine	Ranitidine	Bryant Ranch Prepack	ANDA	Current
63629-1671	Ranitidine	Ranitidine	Bryant Ranch Prepack	ANDA	Current
63629-6757	Ranitidine	Ranitidine	Bryant Ranch Prepack	ANDA	Current
63629-6757	Ranitidine	Ranitidine	Bryant Ranch Prepack	ANDA	Current
63629-7669	Ranitidine	Ranitidine	Bryant Ranch Prepack	ANDA	Current
63629-7669	Ranitidine	Ranitidine	Bryant Ranch Prepack	ANDA	Current
63629-7669	Ranitidine	Ranitidine	Bryant Ranch Prepack	ANDA	Current
63629-8236	Ranitidine	Ranitidine	Bryant Ranch Prepack	ANDA	Current
63629-8236	Ranitidine	Ranitidine	Bryant Ranch Prepack	ANDA	Current
63739-489	Ranitidine	Ranitidine	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-489	Ranitidine	Ranitidine	McKesson Corporation	ANDA	Current
65162-253	Ranitidine	Ranitidine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-253	Ranitidine	Ranitidine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-253	Ranitidine	Ranitidine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-253	Ranitidine	Ranitidine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-254	Ranitidine	Ranitidine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-254	Ranitidine	Ranitidine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-254	Ranitidine	Ranitidine	Amneal Pharmaceuticals LLC	ANDA	Current
65162-254	Ranitidine	Ranitidine	Amneal Pharmaceuticals LLC	ANDA	Current
67046-651	Ranitidine	Ranitidine	Contract Pharmacy Services-PA	ANDA	Current
67046-652	Ranitidine	Ranitidine	Contract Pharmacy Services-PA	ANDA	Current
68071-2190	Ranitidine	Ranitidine	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-2190	Ranitidine	Ranitidine	NuCare Pharmaceuticals, Inc.	ANDA	Current
68151-1610	Ranitidine	Ranitidine	Carilion Materials Management	ANDA	Current