Ranitidine

Product NDC: 67046-649
Requested package NDC: 67046-649-15
11-digit product format: 670460649
Labeler code: 67046
Product ID: 67046-649_5a1cf9b3-6ad1-0805-e053-2991aa0ab837
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ranitidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Contract Pharmacy Services-PA
Application: ANDA078542
Marketing category: ANDA
Marketing start: 2017-09-26
Marketing end: 0000-00-00
Substance: RANITIDINE HYDROCHLORIDE
Active strength: 300 mg/1
Pharmacologic classes: Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67046-649	67046-649-15	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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

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
A078542-001	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL			2008-11-19
A078542-002	RANITIDINE HYDROCHLORIDE	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL			2008-11-19

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 · 84 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
2026-08-18 06:07:40	2026-07	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2008-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2008-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2008-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2008-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2008-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL		2008-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078542-001	RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2008-11-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078542-002	RANITIDINE HYDROCHLORIDE	EQ 300MG BASE	TABLET / ORAL	AB	2008-11-19	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A078542-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078542-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078542-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078542-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078542-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078542-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078542-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078542-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078542-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078542-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078542-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078542-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078542-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078542-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078542-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078542-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078542-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078542-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078542-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078542-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078542-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078542-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078542-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078542-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078542-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078542-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078542-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078542-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078542-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078542-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078542-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078542-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078542-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078542-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078542-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078542-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078542-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078542-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078542-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078542-002	AB	1	`5aa47cf7b7d7…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
67046-649-07	648 Ranitidine 150 mg 649 Ranitidine 300 mg Ranitidine Tablets USP, 150 mg and 300 mg
67046-649-14	648 Ranitidine 150 mg 649 Ranitidine 300 mg Ranitidine Tablets USP, 150 mg and 300 mg
67046-649-15	648 Ranitidine 150 mg 649 Ranitidine 300 mg Ranitidine Tablets USP, 150 mg and 300 mg
67046-649-20	648 Ranitidine 150 mg 649 Ranitidine 300 mg Ranitidine Tablets USP, 150 mg and 300 mg
67046-649-21	648 Ranitidine 150 mg 649 Ranitidine 300 mg Ranitidine Tablets USP, 150 mg and 300 mg
67046-649-28	648 Ranitidine 150 mg 649 Ranitidine 300 mg Ranitidine Tablets USP, 150 mg and 300 mg
67046-649-30	648 Ranitidine 150 mg 649 Ranitidine 300 mg Ranitidine Tablets USP, 150 mg and 300 mg
67046-649-60	648 Ranitidine 150 mg 649 Ranitidine 300 mg Ranitidine Tablets USP, 150 mg and 300 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67046-649-07	Ranitidine	7 in 1 BLISTER PACK	TABLET, FILM COATED	7	1
67046-649-14	Ranitidine	14 in 1 BLISTER PACK	TABLET, FILM COATED	14	1
67046-649-15	Ranitidine	15 in 1 BLISTER PACK	TABLET, FILM COATED	15	1
67046-649-20	Ranitidine	20 in 1 BLISTER PACK	TABLET, FILM COATED	20	1
67046-649-21	Ranitidine	21 in 1 BLISTER PACK	TABLET, FILM COATED	21	1
67046-649-28	Ranitidine	28 in 1 BLISTER PACK	TABLET, FILM COATED	28	1
67046-649-30	Ranitidine	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	1
67046-649-60	Ranitidine	60 in 1 BLISTER PACK	TABLET, FILM COATED	60	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-649	RANITIDINE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1	Legacy NDC, 8 package rows	20170927_5a1cf9b3-6ad2-0805-e053-2991aa0ab837.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BK76465IHM	RANITIDINE HYDROCHLORIDE	66357-59-3	RANITIDINE HYDROCHLORIDE
884KT10YB7	RANITIDINE	66357-35-5	Ranitidine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198191	ranitidine 150 MG Oral Tablet	PSN	5a1cf9b3-6ad2-0805-e053-2991aa0ab837	1
198193	ranitidine 300 MG Oral Tablet	PSN	5a1cf9b3-6ad2-0805-e053-2991aa0ab837	1
198191	ranitidine 150 MG Oral Tablet	SCD	5a1cf9b3-6ad2-0805-e053-2991aa0ab837	1
198193	ranitidine 300 MG Oral Tablet	SCD	5a1cf9b3-6ad2-0805-e053-2991aa0ab837	1
198191	ranitidine 150 MG (as ranitidine HCl 168 MG) Oral Tablet	SY	5a1cf9b3-6ad2-0805-e053-2991aa0ab837	1
198193	ranitidine 300 MG (as ranitidine HCl 336 MG) Oral Tablet	SY	5a1cf9b3-6ad2-0805-e053-2991aa0ab837	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67046-649-15	67046064915	15 TABLET, FILM COATED in 1 BLISTER PACK (67046-649-15)	2017-09-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
648 Ranitidine 150 mg 649 Ranitidine 300 mg Ranitidine Tablets USP, 150 mg and 300 mg	Contract Pharmacy Services-PA \| Coupler Enterprises Inc.	2017-09-26	HUMAN PRESCRIPTION DRUG LABEL	1