Cimetidine

Product NDC: 51655-697
Requested package NDC: 51655-697-51
11-digit product format: 516550697
Labeler code: 51655
Product ID: 51655-697_4950cd76-c47b-d0cf-e063-6394a90acf6d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cimetidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA074246
Marketing category: ANDA
Marketing start: 2021-04-01
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: 2027-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cimetidine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CIMETIDINE	400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
80061L1WGD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197507	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
db482bd8-e68d-3a38-e053-2995a90a38a5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8f48ba86-02a3-4def-9efa-3a8140fd7adf	Product name	2	20250624

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51655-697-51	Cimetidine	40 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	40		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-697	CIMETIDINE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]	3	Current NDC, 1 package rows	20241228_db482bd8-e68d-3a38-e053-2995a90a38a5.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 · 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 ndc (package): 51655-697-51 ndc (product): 51655-697 ndc11 (package): 51655069751
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197507	cimetidine 400 MG Oral Tablet	PSN	db482bd8-e68d-3a38-e053-2995a90a38a5	4
197507	cimetidine 400 MG Oral Tablet	SCD	db482bd8-e68d-3a38-e053-2995a90a38a5	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
51655-697-51	51655069751	40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-697-51)	2021-04-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cimetidine - Northwind Health Company, LLC	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4