Application 074151

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CIMETIDINE	CIMETIDINE	TABLET;ORAL	200MG	No	No
002	CIMETIDINE	CIMETIDINE	TABLET;ORAL	300MG	No	No
003	CIMETIDINE	CIMETIDINE	TABLET;ORAL	400MG	No	No

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

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 · 126 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	A074151-001	CIMETIDINE	200MG	TABLET / ORAL	AB	1994-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074151-002	CIMETIDINE	300MG	TABLET / ORAL	AB	1994-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074151-003	CIMETIDINE	400MG	TABLET / ORAL	AB	1994-05-17	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074151-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074151-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074151-003	AB	1	`caaa826d4ba7…`
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…`

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 ndc (product): 63629-1783
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 ndc (product): 50090-0499 ndc (product): 50090-0500
Cimetidine	CIMETIDINE	Proficient Rx LP	5c2e1f52-4021-4f70-9b2b-63af17094187	2024-04-01	Adverse reactions	Exact identifier application applno (ANDA): 074151 application number: ANDA074151 ndc (product): 63187-333
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 ndc (product): 0093-8204 ndc (product): 0093-8192

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-8192	Cimetidine	Cimetidine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8192	Cimetidine	Cimetidine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8204	Cimetidine	Cimetidine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-8204	Cimetidine	Cimetidine	Teva Pharmaceuticals USA, Inc.	ANDA	Current
10544-626	Cimetidine	Cimetidine	Blenheim Pharmacal, Inc.	ANDA	Current
10544-627	Cimetidine	Cimetidine	Blenheim Pharmacal, Inc.	ANDA	Current
33261-024	Cimetidine	Cimetidine	Aidarex Pharmaceuticals LLC	ANDA	Current
42291-217	Cimetidine	Cimetidine	AvKARE, Inc.	ANDA	Current
42291-217	Cimetidine	Cimetidine	AvKARE, Inc.	ANDA	Current
42291-218	Cimetidine	Cimetidine	AvKARE, Inc.	ANDA	Current
42291-218	Cimetidine	Cimetidine	AvKARE, Inc.	ANDA	Current
50090-0499	Cimetidine	Cimetidine	A-S Medication Solutions	ANDA	Current
50090-0499	Cimetidine	Cimetidine	A-S Medication Solutions	ANDA	Current
50090-0500	Cimetidine	Cimetidine	A-S Medication Solutions	ANDA	Current
50090-0500	Cimetidine	Cimetidine	A-S Medication Solutions	ANDA	Current
53002-3280	Cimetidine	Cimetidine	RPK Pharmaceuticals, Inc.	ANDA	Current
63187-333	Cimetidine	Cimetidine	Proficient Rx LP	ANDA	Current
63187-333	Cimetidine	Cimetidine	Proficient Rx LP	ANDA	Current
63629-1497	Cimetidine	Cimetidine	Bryant Ranch Prepack	ANDA	Current
63629-1497	Cimetidine	Cimetidine	Bryant Ranch Prepack	ANDA	Current
63629-1783	Cimetidine	Cimetidine	Bryant Ranch Prepack	ANDA	Current
63629-1783	Cimetidine	Cimetidine	Bryant Ranch Prepack	ANDA	Current
66267-057	Cimetidine	Cimetidine	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-057	Cimetidine	Cimetidine	NuCare Pharmaceuticals, Inc.	ANDA	Current
68151-1742	Cimetidine	Cimetidine	Carilion Materials Management	ANDA	Current
68151-2899	Cimetidine	Cimetidine	Carilion Materials Management	ANDA	Current
68788-9064	Cimetidine	Cimetidine	Preferred Pharmaceuticals, Inc.	ANDA	Current
70934-931	Cimetidine	Cimetidine	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-931	Cimetidine	Cimetidine	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current