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 43.

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 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091429-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091429-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2011-05-11	`4b0b4de00fa7…`
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…`

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 2 of 2 · 108 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55312-950	acid relief	Ranitidine	Western Family Foods Inc	ANDA	Current
55316-852	Healthy Accents Ranitidine	Ranitidine	DZA Brands LLC	ANDA	Current
55319-523	Family Wellness Acid Reducer 150	Ranitidine	Family Dollar Services Inc	ANDA	Current
55319-852	Family Wellness Acid Reducer 150	Ranitidine	Family Dollar Services Inc	ANDA	Current
55319-852	Family Wellness Acid Reducer 150	Ranitidine	Family Dollar Services Inc	ANDA	Current
55910-011	dg health heartburn relief	Ranitidine	Dolgencorp, LLC	ANDA	Current
55910-423	dg health acid reducer	Ranitidine	Dolgencorp, LLC	ANDA	Current
55910-852	DG Health Acid Reducer	Ranitidine	Dolgencorp, LLC	ANDA	Current
55910-852	DG Health Acid Reducer	Ranitidine	Dolgencorp, LLC	ANDA	Current
56062-099	heartburn relief	Ranitidine	Publix Super Markets Inc	ANDA	Current
56062-099	heartburn relief	Ranitidine	Publix Super Markets Inc	ANDA	Current
56062-099	heartburn relief	Ranitidine	Publix Super Markets Inc	ANDA	Current
56062-852	maximum strength ranitidine	Ranitidine	Publix Super Markets Inc	ANDA	Current
59779-540	acid reducer	Ranitidine	CVS Pharmacy	ANDA	Current
59779-540	acid reducer	Ranitidine	CVS Pharmacy	ANDA	Current
59779-950	acid reducer	Ranitidine	CVS Pharmacy	ANDA	Current
62011-0282	Health Mart acid reducer	Ranitidine	Strategic Sourcing Services LLC	ANDA	Current
62011-0282	Health Mart acid reducer	Ranitidine	Strategic Sourcing Services LLC	ANDA	Current
62011-0282	Health Mart acid reducer	Ranitidine	Mckesson	ANDA	Current
63981-852	Kirkland Signature Acid Reducer	Ranitidine	Costco Wholesale Company	ANDA	Current
68391-837	Berkley and Jensen Ranitidine	Ranitidine	BJWC	ANDA	Current
68391-852	Berkley and Jensen Ranitidine	Ranitidine	BJWC	ANDA	Current
69256-041	harris teeter acid reducer 150	Ranitidine	Harris Teeter, LLC	ANDA	Current
70000-0377	Leader Ranitidine	Ranitidine	Cardinal Health	ANDA	Current
70000-0377	Leader Ranitidine	Ranitidine	Cardinal Health	ANDA	Current
70000-0378	leader acid control	Ranitidine	Cardinal Health	ANDA	Current
70000-0378	leader acid control	Ranitidine	Cardinal Health	ANDA	Current
71141-013	Ranitidine	Ranitidine	Lidl US LLC	ANDA	Current