Ranitidine

Product NDC: 0121-0727
11-digit product format: 001210727
Labeler code: 0121
Product ID: 0121-0727_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
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 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
2026-08-18 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…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077405-001	RANITIDINE HYDROCHLORIDE	EQ 15MG BASE/ML	SYRUP / ORAL	AA	RS	2007-09-21	`e64feba35796…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ranitidine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RANITIDINE	15 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
884KT10YB7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
705610	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d0da9dd6-c691-4614-99c7-531b0bf34837	Available on FDA.report

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
0121-0727-16	Ranitidine	473 mL in 1 BOTTLE	SYRUP	473		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-0727-16	ML - Milliliter	0121-0727	3875e311-254e-4d50-bcc2-e8105917adf6	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
0121-0727	RANITIDINE SYRUP [PHARMACEUTICAL ASSOCIATES, INC.]	8	Current NDC, Legacy NDC, 1 package rows	20220113_d0da9dd6-c691-4614-99c7-531b0bf34837.zip

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	Pharmaceutical Associates, Inc.	d0da9dd6-c691-4614-99c7-531b0bf34837	2022-01-12	Adverse reactions	Exact identifier application applno (ANDA): 077405 application number: ANDA077405 ndc (product): 0121-0727

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
705610	ranitidine 15 MG/ML Oral Solution	SCD	6a10f978-be03-1362-e053-2991aa0a4c1f	4
705610	ranitidine 15 MG (as ranitidine HCl 16.8 MG) per 1 ML Oral Solution	SY	6a10f978-be03-1362-e053-2991aa0a4c1f	4
705610	ranitidine 75 MG per 5 ML Syrup	SY	6a10f978-be03-1362-e053-2991aa0a4c1f	4
705610	ranitidine 15 MG/ML Oral Solution	SCD	361f8a7e-eeba-4941-9868-eaffbc04ba7e	3
705610	ranitidine 15 MG (as ranitidine HCl 16.8 MG) per 1 ML Oral Solution	SY	361f8a7e-eeba-4941-9868-eaffbc04ba7e	3
705610	ranitidine 75 MG per 5 ML Syrup	SY	361f8a7e-eeba-4941-9868-eaffbc04ba7e	3
705610	ranitidine 15 MG/ML Oral Solution	SCD	817c4a6c-a89c-4d86-87a3-895bbc8fb4ad	2
705610	ranitidine 15 MG (as ranitidine HCl 16.8 MG) per 1 ML Oral Solution	SY	817c4a6c-a89c-4d86-87a3-895bbc8fb4ad	2
705610	ranitidine 75 MG per 5 ML Syrup	SY	817c4a6c-a89c-4d86-87a3-895bbc8fb4ad	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-0727-16	00121072716	473 mL in 1 BOTTLE (0121-0727-16)	473 ml	2010-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ranitidine soln	RedPharm Drug, Inc.	2022-01-21	HUMAN PRESCRIPTION DRUG LABEL	4
Ranitidine Syrup (Ranitidine Oral Solution USP)	Pharmaceutical Associates, Inc.	2022-01-12	HUMAN PRESCRIPTION DRUG LABEL	8
Ranitidine Syrup (Ranitidine Oral Solution USP)	Preferred Pharmaceuticals Inc.	2019-03-19	HUMAN PRESCRIPTION DRUG LABEL	2
Ranitidine Syrup (Ranitidine Oral Solution USP)	Unit Dose Services	2018-05-24	HUMAN PRESCRIPTION DRUG LABEL	2
Ranitidine Syrup (Ranitidine Oral Solution USP)	ATLANTIC BIOLOGICALS CORP.	2016-08-29	HUMAN PRESCRIPTION DRUG LABEL	3