Ranitidine Hydrochloride

Manufacturer: Zydus Lifesciences Limited
Effective date: 2022-11-05
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-01 21:49:29

Label at a glance#

ProductRanitidine Hydrochloride

Active ingredientRANITIDINE HYDROCHLORIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 40 mL Vial Container Label

NDC 72785-0001-1

Ranitidine Injection USP

1000 mg/40 mL

(25 mg/mL*)

40-mL Pharmacy Bulk package – Not for Direct Infusion

Sterile

Rx only

Zydus pharmaceuticals

PRINCIPAL DISPLAY PANEL - 40 mL Vial Carton Label

NDC 72785-0001-1

Ranitidine Injection USP

1000 mg/40 mL

(25 mg/mL*)

40-mL Pharmacy Bulk Package – Not for Direct Infusion

Sterile

Rx only

Zydus pharmaceuticals

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72785-0001	RANITIDINE HYDROCHLORIDE INJECTION, SOLUTION [ZYDUS LIFESCIENCES LIMITED]	4	Legacy NDC	20221108_82ec17ea-a7e0-43a2-bc23-f96c3aaaa045.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

Ranitidine Hydrochloride
RANITIDINE
PHENOL
POTASSIUM PHOSPHATE, MONOBASIC
SODIUM PHOSPHATE, DIBASIC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
72785-0001	72785-0001-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
RANITIDINE HYDROCHLORIDE	BK76465IHM	ACTIM
PHENOL	339NCG44TV	IACT
POTASSIUM PHOSPHATE, MONOBASIC	4J9FJ0HL51	IACT
SODIUM PHOSPHATE, DIBASIC	GR686LBA74	IACT

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A091534-001	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION			2013-02-22

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION	AP	2013-02-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION	AP	2013-02-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION	AP	2013-02-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION	AP	2013-02-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION	AP	2013-02-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION	AP	2013-02-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION	AP	2013-02-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION	AP	2013-02-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION	AP	2013-02-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION	AP	2013-02-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION	AP	2013-02-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION	AP	2013-02-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION	AP	2013-02-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION		2013-02-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION	AP	2013-02-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION	AP	2013-02-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION	AP	2013-02-22	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091534-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091534-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091534-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091534-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091534-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091534-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091534-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091534-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091534-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091534-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091534-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091534-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091534-001	AP	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A091534-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091534-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091534-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091534-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091534-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091534-001	AP	1	`cb3db0bc1861…`

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
47279e12-6017-4bab-9579-c98dca46e144			82ec17ea-a7e0-43a2-bc23-f96c3aaaa045	2025-06-26		Exact identifier spl set id: 82ec17ea-a7e0-43a2-bc23-f96c3aaaa045

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.