Cimetidine

Product NDC: 70934-931
Requested package NDC: 70934-931-30
11-digit product format: 709340931
Labeler code: 70934
Product ID: 70934-931_f174e1bf-fabf-a225-e053-2a95a90abbbf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cimetidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application: ANDA074151
Marketing category: ANDA
Marketing start: 2021-11-24
Marketing end: 2024-07-31
Substance: CIMETIDINE
Active strength: 400 mg/1
Pharmacologic classes: Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	70934-931	70934-931-30	D	Discontinued by firm		2026-08-03

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 · 11 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…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A074151-001	CIMETIDINE	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17
A074151-002	CIMETIDINE	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17
A074151-003	CIMETIDINE	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A074151-001	AB
A074151-002	AB
A074151-003	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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A074151-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074151-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074151-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074151-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074151-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074151-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074151-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074151-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074151-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074151-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074151-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074151-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074151-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074151-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074151-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074151-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074151-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074151-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074151-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074151-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074151-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074151-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074151-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074151-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074151-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074151-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074151-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074151-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074151-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074151-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074151-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074151-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074151-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074151-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074151-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074151-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074151-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074151-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074151-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074151-001	AB	1	`8072bd15b7f6…`

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	Bryant Ranch Prepack	0ab5ea2b-bd2f-49ec-9e92-033bed998797	2026-03-09	Adverse reactions	Exact identifier application applno (ANDA): 074151 application number: ANDA074151
Cimetidine	CIMETIDINE	A-S Medication Solutions	cf1626a1-ccf6-4759-b2ab-22c7f3873d84	2024-11-08	Adverse reactions	Exact identifier application applno (ANDA): 074151 application number: ANDA074151
Cimetidine	CIMETIDINE	Proficient Rx LP	5c2e1f52-4021-4f70-9b2b-63af17094187	2024-04-01	Adverse reactions	Exact identifier application applno (ANDA): 074151 application number: ANDA074151
Cimetidine	CIMETIDINE	Teva Pharmaceuticals USA, Inc.	496e258d-a5fd-42da-9a86-73afc8be359b	2022-11-30	Adverse reactions	Exact identifier application applno (ANDA): 074151 application number: ANDA074151

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
70934-931-30	70934093130	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-931-30)	2021-11-24	2024-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CIMETIDINE TABLETS USP 8192 8204 8305 Rx only	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-04	HUMAN PRESCRIPTION DRUG LABEL	2