Ranitidine

Product NDC: 0121-4727
11-digit product format: 001214727
Labeler code: 0121
Product ID: 0121-4727_d56a22ea-5dab-e98a-e053-2a95a90a34c4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: RANITIDINE
Dosage form: SYRUP
Route: ORAL
Labeler: Pharmaceutical Associates, Inc.
Application: ANDA077405
Marketing category: ANDA
Marketing start: 2010-11-01
Marketing end: 0000-00-00
Substance: RANITIDINE
Active strength: 15 mg/mL
Pharmacologic classes: Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	0121-4727		D	Discontinued by firm		2026-11-13
excluded package	package	0121-4727	0121-4727-10	D	Discontinued by firm		2026-11-13

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

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
A077405-001	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL			2007-09-21

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 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-11-14 07:37:17	2026-10	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL			2007-09-21	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL			2007-09-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL			2007-09-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL			2007-09-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL			2007-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL			2007-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL			2007-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL			2007-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL			2007-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL			2007-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL			2007-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL			2007-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL			2007-09-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL			2007-09-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL			2007-09-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL			2007-09-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL			2007-09-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL			2007-09-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`3bdfa0b2c4d7…`

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	A077405-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077405-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077405-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077405-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077405-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077405-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077405-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077405-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077405-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077405-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077405-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077405-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077405-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077405-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077405-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077405-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077405-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077405-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077405-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077405-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077405-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077405-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077405-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077405-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077405-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077405-001	AA	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0121-4727-10	Ranitidine	10 in 1 TRAY	SYRUP	10		8
0121-4727-10	Ranitidine	4 in 1 CASE	SYRUP	4		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-4727-10	ML - Milliliter	0121-4727	1a07bbe4-10ce-4619-8608-7b9bdab8e8b3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Ranitidine	ACTIVE INGREDIENT	884KT10YB7	RANITIDINE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	4
Ranitidine	ACTIVE MOIETY	884KT10YB7	RANITIDINE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-4727	RANITIDINE SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]	8	Legacy NDC, 2 package rows	20220113_d0da9dd6-c691-4614-99c7-531b0bf34837.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
884KT10YB7	RANITIDINE	66357-35-5	RANITIDINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
705610	ranitidine 15 MG/ML Oral Solution	SCD	d0da9dd6-c691-4614-99c7-531b0bf34837	8
705610	ranitidine 15 MG (as ranitidine HCl 16.8 MG) per 1 ML Oral Solution	SY	d0da9dd6-c691-4614-99c7-531b0bf34837	8
705610	ranitidine 75 MG per 5 ML Syrup	SY	d0da9dd6-c691-4614-99c7-531b0bf34837	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-4727-10	00121472710	4 TRAY in 1 CASE (0121-4727-10) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE	4 tray	2010-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ranitidine Syrup (Ranitidine Oral Solution USP)	Pharmaceutical Associates, Inc.	2022-01-12	HUMAN PRESCRIPTION DRUG LABEL	8