Regular Strength Acid Reducer

Product NDC: 55319-352
11-digit product format: 553190352
Labeler code: 55319
Product ID: 55319-352_3cff4f08-e8e4-4324-a08b-9970c25665c4
Type: HUMAN OTC DRUG
Nonproprietary name: Ranitidine
Dosage form: TABLET
Route: ORAL
Labeler: Family Dollar
Application: ANDA201745
Marketing category: ANDA
Marketing start: 2013-09-24
Marketing end: 0000-00-00
Substance: RANITIDINE HYDROCHLORIDE
Active strength: 75 mg/1
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55319-352		I	Inactivated by FDA		2026-08-17
excluded package	package	55319-352	55319-352-30	I	Inactivated by FDA		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 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55319-352-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55319-352-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55319-352-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55319-352-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55319-352-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55319-352-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55319-352-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55319-352-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55319-352-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55319-352-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55319-352-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55319-352-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55319-352-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55319-352-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55319-352-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55319-352-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55319-352-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55319-352-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	55319-352-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	55319-352-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	55319-352-30	`9bebd1f3094a…`	`5416666fcb17…`

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
A201745-001	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL			2012-02-29

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	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201745-001	RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2012-02-29	`e64feba35796…`

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
55319-352-30	2020-01-31	C162847	48780-1	9d75b9d0-0d90-f424-e053-dadaa90a57ce	Family Wellness

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55319-352-30	Regular Strength Acid Reducer	30 in 1 BOTTLE	TABLET	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RANITIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	BK76465IHM	REGULAR STRENGTH ACID REDUCER (RANITIDINE) TABLET [FAMILY DOLLAR]	1
RANITIDINE	ACTIVE MOIETY	884KT10YB7	REGULAR STRENGTH ACID REDUCER (RANITIDINE) TABLET [FAMILY DOLLAR]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	REGULAR STRENGTH ACID REDUCER (RANITIDINE) TABLET [FAMILY DOLLAR]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	REGULAR STRENGTH ACID REDUCER (RANITIDINE) TABLET [FAMILY DOLLAR]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	REGULAR STRENGTH ACID REDUCER (RANITIDINE) TABLET [FAMILY DOLLAR]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	REGULAR STRENGTH ACID REDUCER (RANITIDINE) TABLET [FAMILY DOLLAR]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	REGULAR STRENGTH ACID REDUCER (RANITIDINE) TABLET [FAMILY DOLLAR]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	REGULAR STRENGTH ACID REDUCER (RANITIDINE) TABLET [FAMILY DOLLAR]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	REGULAR STRENGTH ACID REDUCER (RANITIDINE) TABLET [FAMILY DOLLAR]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	REGULAR STRENGTH ACID REDUCER (RANITIDINE) TABLET [FAMILY DOLLAR]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	REGULAR STRENGTH ACID REDUCER (RANITIDINE) TABLET [FAMILY DOLLAR]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55319-352	REGULAR STRENGTH ACID REDUCER (RANITIDINE) TABLET [FAMILY DOLLAR]	1	Legacy NDC, 1 package rows	20141104_3cff4f08-e8e4-4324-a08b-9970c25665c4.zip

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
Acid Reducer	RANITIDINE HYDROCHLORIDE	WinCo Foods, LLC	70bc7062-ab3c-43eb-b524-0d8c6d1a674d	2014-12-10	Warnings	Exact identifier application applno (ANDA): 201745 application number: ANDA201745

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
312773	ranitidine 75 MG Oral Tablet	PSN	3cff4f08-e8e4-4324-a08b-9970c25665c4	1
312773	ranitidine 75 MG Oral Tablet	SCD	3cff4f08-e8e4-4324-a08b-9970c25665c4	1
312773	ranitidine 75 MG (as ranitidine hydrochloride 84 MG) Oral Tablet	SY	3cff4f08-e8e4-4324-a08b-9970c25665c4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
55319-352-30	55319035230	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Family Wellness	Family Dollar \| Ranbaxy Pharmaceuticals Inc. \| Shasun Pharmaceuticals Limited	2014-10-13	HUMAN OTC DRUG LABEL	1