Ranitidine Injection, USP

Manufacturer: Zydus Lifesciences Limited
Effective date: 2022-11-05
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 7
Source: legacy-cache
Hydrated at: 2026-08-01 21:49:30

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 - 2 mL Vial Container Label

NDC 65841-763-02

Ranitidine Injection, USP

50 mg/2 mL (25 mg/mL)*

For IV or IM Injection, or IV Infusion

2 mL Single-Use Vial

Sterile

Rx only

Zydus Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton Label

NDC 65841-763-02

Ranitidine Injection, USP

50 mg/2 mL (25 mg/mL)*

For IV or IM Injection, or IV Infusion

10 X 2 mL Single-Use Vials

Rx only

Sterile

Zydus Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 6 mL Vial Container Label

NDC 65841-764-06

Ranitidine Injection, USP

150 mg/6 mL (25 mg/mL)*

For IV or IM Injection, or IV Infusion

6 mL Multi-Dose Vial

Sterile

Rx only

Zydus Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 6 mL Vial Carton Label

NDC 65841-764-06

Ranitidine Injection, USP

150 mg/6 mL (25 mg/mL)*

For IV or IM Injection, or IV Infusion

6 mL Multi-Dose Vial

Sterile

Rx only

Zydus Pharmaceuticals

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-763	RANITIDINE HYDROCHLORIDE INJECTION [ZYDUS LIFESCIENCES LIMITED]	7	Legacy NDC	20221108_9268c1df-bcf3-4899-896d-044492802a33.zip
65841-764	RANITIDINE HYDROCHLORIDE INJECTION [ZYDUS LIFESCIENCES LIMITED]	7	Legacy NDC	20221108_9268c1df-bcf3-4899-896d-044492802a33.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
RANITIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	BK76465IHM	2
RANITIDINE	ACTIVE MOIETY	884KT10YB7	2
PHENOL	INACTIVE INGREDIENT	339NCG44TV	2
POTASSIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	4J9FJ0HL51	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	2

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
65841-763	65841-763-02
65841-764	65841-764-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
RANITIDINE HYDROCHLORIDE	BK76465IHM	ACTIM
PHENOL	339NCG44TV	IACT
POTASSIUM PHOSPHATE, MONOBASIC	4J9FJ0HL51	IACT
SODIUM PHOSPHATE, DIBASIC	GR686LBA74	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 52 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION / SUBCUTANEOUS		14 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION / INTRA-ARTICULAR	0.5 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION, SOLUTION / SUBCUTANEOUS	0.55 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	FILM, SOLUBLE / ORAL		9 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION / INTRADERMAL	0.2 %w/v		Exact identifier — unii candidate 14 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASIC	MONOBASIC POTASSIUM PHOSPHATE	4J9FJ0HL51	SOLUTION / NASAL	680 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION / INTRAVENOUS	200 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASIC	MONOBASIC POTASSIUM PHOSPHATE	4J9FJ0HL51	SOLUTION / ORAL		287 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASIC	MONOBASIC POTASSIUM PHOSPHATE	4J9FJ0HL51	TABLET, EXTENDED RELEASE / ORAL	4 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	TABLET, EXTENDED RELEASE / ORAL		143 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASIC	MONOBASIC POTASSIUM PHOSPHATE	4J9FJ0HL51	SUSPENSION / ORAL	50 mg/5ml		Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	SUSPENSION / OPHTHALMIC	0.43 %w/w		Exact identifier — unii candidate 14 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASIC	MONOBASIC POTASSIUM PHOSPHATE	4J9FJ0HL51	TABLET / ORAL	25 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASIC	MONOBASIC POTASSIUM PHOSPHATE	4J9FJ0HL51	SUSPENSION / OPHTHALMIC	0.44 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION / INTRAVENOUS		48 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION, SOLUTION / INTRAMUSCULAR		75 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	40 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASIC	MONOBASIC POTASSIUM PHOSPHATE	4J9FJ0HL51	SYRUP / ORAL		19 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASIC	MONOBASIC POTASSIUM PHOSPHATE	4J9FJ0HL51	CAPSULE, DELAYED RELEASE PELLETS / ORAL		272 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 14 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION / INTRAMUSCULAR		48 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	DOUCHE / VAGINAL	0.14 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	LIQUID / INTRAVENOUS	0.5 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION / INTRALESIONAL	0.5 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASIC	MONOBASIC POTASSIUM PHOSPHATE	4J9FJ0HL51	INJECTION, SOLUTION / INTRAVESICAL	29.2 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION / INTRAMUSCULAR	40 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASIC	MONOBASIC POTASSIUM PHOSPHATE	4J9FJ0HL51	SPRAY / NASAL		3 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION, SUSPENSION / SUBCUTANEOUS	0.07 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	SOLUTION / INTRAVENOUS		23 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASIC	MONOBASIC POTASSIUM PHOSPHATE	4J9FJ0HL51	INJECTION / INTRAVENOUS	68 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS	2.98 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	40 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	2 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASIC	MONOBASIC POTASSIUM PHOSPHATE	4J9FJ0HL51	INJECTION / SUBCUTANEOUS		8 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASIC	MONOBASIC POTASSIUM PHOSPHATE	4J9FJ0HL51	SOLUTION / AURICULAR (OTIC)	0.2 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION / SUBCUTANEOUS		48 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASIC	MONOBASIC POTASSIUM PHOSPHATE	4J9FJ0HL51	INJECTION / INTRAMUSCULAR	0.3 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION, SOLUTION / INTRAVENOUS		75 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	SOLUTION / ORAL	40 mg/1ml		Exact identifier — unii candidate 14 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASIC	MONOBASIC POTASSIUM PHOSPHATE	4J9FJ0HL51	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		110 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION / INTRASYNOVIAL	0.5 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	CONCENTRATE / ORAL	17 mg/5ml		Exact identifier — unii candidate 14 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASIC	MONOBASIC POTASSIUM PHOSPHATE	4J9FJ0HL51	SOLUTION / OPHTHALMIC	0.2 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASIC	MONOBASIC POTASSIUM PHOSPHATE	4J9FJ0HL51	INJECTION, SOLUTION / INTRAVENOUS	1.36 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	LIQUID / SUBCUTANEOUS	0.5 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	SYRUP / ORAL		70 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASIC	MONOBASIC POTASSIUM PHOSPHATE	4J9FJ0HL51	CAPSULE, COATED PELLETS / ORAL		272 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM PHOSPHATE, MONOBASIC	MONOBASIC POTASSIUM PHOSPHATE	4J9FJ0HL51	INJECTION / INTRA-ARTICULAR	0.3 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	2 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION / INTRADERMAL	0.25 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	2 mg		Exact identifier — unii candidate 19 equally ranked IID candidates

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 43.

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 · 43 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
2026-09-14 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…`
2022-10-28 04:53 UTC	2022-10	A091534-001	RANITIDINE HYDROCHLORIDE	EQ 25MG BASE/ML	INJECTABLE / INJECTION	AP	2013-02-22	`f41ea6bd6efb…`

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
e8ab4530-a4cf-4763-9eb3-db0981ed3bc3			9268c1df-bcf3-4899-896d-044492802a33	2025-06-26		Exact identifier spl set id: 9268c1df-bcf3-4899-896d-044492802a33

Reported adverse events (FAERS/openFDA)#

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