Ranitidine 150

Product NDC: 69168-397
Requested package NDC: 69168-397-29
11-digit product format: 691680397
Labeler code: 69168
Product ID: 69168-397_269ed013-0691-4a9c-944b-5702f022eee1
Type: HUMAN OTC DRUG
Nonproprietary name: Ranitidine HCl Tablets 150mg
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Allegiant Health
Application: ANDA210243
Marketing category: ANDA
Marketing start: 2018-10-01
Marketing end: 2021-04-30
Substance: RANITIDINE HYDROCHLORIDE
Active strength: 150 mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	69168-397	69168-397-29	D	Discontinued by firm		2026-08-03

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69168-397-29	69168039729	1 BLISTER PACK in 1 CARTON (69168-397-29) > 8 TABLET, COATED in 1 BLISTER PACK	1 blister pack	2018-10-01	2021-04-30	No	No	Current

Ranitidine 150

NDC auxiliary status#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#