Cimetidine

Product NDC: 70518-2809
11-digit product format: 705182809
Labeler code: 70518
Product ID: 70518-2809_d733730f-84e1-70e0-e053-2995a90acd24
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cimetidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA074246
Marketing category: ANDA
Marketing start: 2020-07-09
Marketing end: 0000-00-00
Substance: CIMETIDINE
Active strength: 200 mg/1
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	70518-2809		D	Discontinued by firm		2026-08-11
excluded package	package	70518-2809	70518-2809-0	D	Discontinued by firm		2026-08-11

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-2809-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-2809-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-2809-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-2809-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-2809-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-2809-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-2809-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-2809-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-2809-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-2809-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-2809-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-2809-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074246-001	CIMETIDINE	CIMETIDINE	200MG	TABLET / ORAL	AB		1994-05-17
A074246-002	CIMETIDINE	CIMETIDINE	300MG	TABLET / ORAL	AB		1994-05-17
A074246-003	CIMETIDINE	CIMETIDINE	400MG	TABLET / ORAL	AB		1994-05-17
A074246-004	CIMETIDINE	CIMETIDINE	800MG	TABLET / ORAL	AB	RS	1994-05-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A074246-001	AB
A074246-002	AB
A074246-003	AB
A074246-004	AB

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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	A074246-001	CIMETIDINE	200MG	TABLET / ORAL	AB		1994-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074246-002	CIMETIDINE	300MG	TABLET / ORAL	AB		1994-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074246-003	CIMETIDINE	400MG	TABLET / ORAL	AB		1994-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074246-004	CIMETIDINE	800MG	TABLET / ORAL	AB	RS	1994-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074246-001	CIMETIDINE	200MG	TABLET / ORAL	AB		1994-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074246-002	CIMETIDINE	300MG	TABLET / ORAL	AB		1994-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074246-003	CIMETIDINE	400MG	TABLET / ORAL	AB		1994-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074246-004	CIMETIDINE	800MG	TABLET / ORAL	AB	RS	1994-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074246-001	CIMETIDINE	200MG	TABLET / ORAL	AB		1994-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074246-002	CIMETIDINE	300MG	TABLET / ORAL	AB		1994-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074246-003	CIMETIDINE	400MG	TABLET / ORAL	AB		1994-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074246-004	CIMETIDINE	800MG	TABLET / ORAL	AB	RS	1994-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074246-001	CIMETIDINE	200MG	TABLET / ORAL	AB		1994-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074246-002	CIMETIDINE	300MG	TABLET / ORAL	AB		1994-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074246-003	CIMETIDINE	400MG	TABLET / ORAL	AB		1994-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074246-004	CIMETIDINE	800MG	TABLET / ORAL	AB	RS	1994-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074246-001	CIMETIDINE	200MG	TABLET / ORAL	AB		1994-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074246-002	CIMETIDINE	300MG	TABLET / ORAL	AB		1994-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074246-003	CIMETIDINE	400MG	TABLET / ORAL	AB		1994-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074246-004	CIMETIDINE	800MG	TABLET / ORAL	AB	RS	1994-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074246-001	CIMETIDINE	200MG	TABLET / ORAL	AB		1994-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074246-002	CIMETIDINE	300MG	TABLET / ORAL	AB		1994-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074246-003	CIMETIDINE	400MG	TABLET / ORAL	AB		1994-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074246-004	CIMETIDINE	800MG	TABLET / ORAL	AB	RS	1994-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074246-001	CIMETIDINE	200MG	TABLET / ORAL	AB		1994-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074246-002	CIMETIDINE	300MG	TABLET / ORAL	AB		1994-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074246-003	CIMETIDINE	400MG	TABLET / ORAL	AB		1994-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074246-004	CIMETIDINE	800MG	TABLET / ORAL	AB	RS	1994-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074246-001	CIMETIDINE	200MG	TABLET / ORAL	AB		1994-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074246-002	CIMETIDINE	300MG	TABLET / ORAL	AB		1994-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074246-003	CIMETIDINE	400MG	TABLET / ORAL	AB		1994-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074246-004	CIMETIDINE	800MG	TABLET / ORAL	AB	RS	1994-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074246-001	CIMETIDINE	200MG	TABLET / ORAL	AB		1994-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074246-002	CIMETIDINE	300MG	TABLET / ORAL	AB		1994-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074246-003	CIMETIDINE	400MG	TABLET / ORAL	AB		1994-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074246-004	CIMETIDINE	800MG	TABLET / ORAL	AB	RS	1994-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074246-001	CIMETIDINE	200MG	TABLET / ORAL	AB		1994-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074246-002	CIMETIDINE	300MG	TABLET / ORAL	AB		1994-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074246-003	CIMETIDINE	400MG	TABLET / ORAL	AB		1994-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074246-004	CIMETIDINE	800MG	TABLET / ORAL	AB	RS	1994-05-17	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074246-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074246-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074246-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074246-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074246-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074246-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074246-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074246-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074246-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074246-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074246-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074246-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074246-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074246-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074246-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074246-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074246-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074246-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074246-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074246-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074246-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074246-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074246-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074246-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074246-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074246-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074246-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074246-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074246-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074246-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074246-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074246-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074246-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074246-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074246-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074246-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074246-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074246-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074246-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074246-004	AB	1	`d06236e962d9…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2809-0	2022-02-04	C162847	48780-1	d6a99b39-c751-a426-e053-dadaa90af4c2	e3ec4574-7f79-4d9a-865b-830675e94e90
70518-2809-0	2022-01-28	C162847	48780-1	d6a99b39-c751-a426-e053-dadaa90af4c2	e3ec4574-7f79-4d9a-865b-830675e94e90

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cimetidine	CIMETIDINE	Northwind Health Company, LLC	db482bd8-e68d-3a38-e053-2995a90a38a5	2026-01-01	Adverse reactions	Exact identifier application applno (ANDA): 074246 application number: ANDA074246
Cimetidine	CIMETIDINE	PD-Rx Pharmaceuticals, Inc.	28fd7158-a617-436a-8f5c-71ffbaafe527	2025-10-20	Adverse reactions	Exact identifier application applno (ANDA): 074246 application number: ANDA074246
Cimetidine	CIMETIDINE	A-S Medication Solutions	28fa98b3-6c78-4b7b-9a37-84c879dbf58a	2025-05-02	Adverse reactions	Exact identifier application applno (ANDA): 074246 application number: ANDA074246
Cimetidine	CIMETIDINE	Mylan Pharmaceuticals Inc.	06c0a509-026f-44e0-9975-a94a8de51d43	2019-08-15	Adverse reactions	Exact identifier application applno (ANDA): 074246 application number: ANDA074246

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
80061L1WGD	CIMETIDINE	51481-61-9	CIMETIDINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2809-0	70518280900	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2809-0)	2020-07-09	0000-00-00	No	No	Current