Acid Reducer

Product NDC: 37808-196
Requested package NDC: 37808-196-01
11-digit product format: 378080196
Labeler code: 37808
Product ID: 37808-196_84772d1b-806f-31ec-e053-2a91aa0aeb27
Type: HUMAN OTC DRUG
Nonproprietary name: Ranitidine
Dosage form: TABLET
Route: ORAL
Labeler: HEB
Application: ANDA210243
Marketing category: ANDA
Marketing start: 2018-10-20
Marketing end: 0000-00-00
Substance: RANITIDINE HYDROCHLORIDE
Active strength: 150 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	37808-196	37808-196-01	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37808-196	37808-196-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37808-196	37808-196-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	37808-196	37808-196-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	37808-196	37808-196-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	37808-196	37808-196-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	37808-196	37808-196-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	37808-196	37808-196-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	37808-196	37808-196-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37808-196	37808-196-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	37808-196	37808-196-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	37808-196	37808-196-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	37808-196	37808-196-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A210243-001	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2018-08-20
A210243-002	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2018-08-20

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210243-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210243-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210243-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210243-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210243-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210243-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210243-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210243-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210243-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210243-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210243-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210243-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210243-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210243-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210243-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210243-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210243-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210243-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210243-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210243-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210243-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210243-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210243-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210243-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210243-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210243-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210243-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210243-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210243-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210243-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210243-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210243-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210243-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210243-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210243-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210243-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210243-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210243-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210243-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210243-002	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2018-08-20	`782e0a99824c…`

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	Granules India Ltd	aab81d9f-397d-49fb-8083-77a1872cc71f	2025-12-02	Warnings	Exact identifier application applno (ANDA): 210243 application number: ANDA210243

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-196-01	37808019601	1 BOTTLE, PLASTIC in 1 CARTON (37808-196-01) > 24 TABLET in 1 BOTTLE, PLASTIC	2018-12-31	0000-00-00	No	No	Current