heartburn prevention

Product NDC: 59640-022
11-digit product format: 596400022
Labeler code: 59640
Product ID: 59640-022_d578977f-3c3e-4a72-87bd-2f915938f146
Type: HUMAN OTC DRUG
Nonproprietary name: Cimetidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: H E B
Application: ANDA075285
Marketing category: ANDA
Marketing start: 2022-11-04
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: 2026-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075285-001	CIMETIDINE	CIMETIDINE	200MG	TABLET / ORAL			1998-10-29

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075285-001	CIMETIDINE	200MG	TABLET / ORAL	1998-10-29	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: heartburn prevention
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CIMETIDINE	200 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
197505	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
f7156440-f2d8-4292-a436-388622ff3965	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
59640-022-72	heartburn prevention	1 in 1 CARTON	TABLET, FILM COATED	1		3
59640-022-72	heartburn prevention	60 in 1 BOTTLE	TABLET, FILM COATED	60		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59640-022	HEARTBURN PREVENTION (CIMETIDINE) TABLET, FILM COATED [H E B]	2	Current NDC, Legacy NDC, 2 package rows	20221118_f7156440-f2d8-4292-a436-388622ff3965.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACID CONTROLLER	CIMETIDINE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	cf772ee0-680a-4e1c-8c5d-929756896b36	2026-05-11	Warnings	Exact identifier application applno (ANDA): 075285 application number: ANDA075285
heartburn prevention	CIMETIDINE	H E B	f7156440-f2d8-4292-a436-388622ff3965	2025-08-26	Warnings	Exact identifier application applno (ANDA): 075285 application number: ANDA075285 ndc (product): 59640-022
cimetidine 200 acid reducer	CIMETIDINE	Walgreen Company	7087f4bb-992b-4680-a9a7-452ce74eed2d	2025-03-10	Warnings	Exact identifier application applno (ANDA): 075285 application number: ANDA075285
Equate Cimetidine	CIMETIDINE	Wal-Mart Stores Inc	ad3e8f6a-8e35-42c2-a98c-566a2868e923	2022-03-10	Warnings	Exact identifier application applno (ANDA): 075285 application number: ANDA075285
basic care acid reducer	CIMETIDINE	Amazon.com Services LLC	ffba8756-b9de-4d18-85fa-b4dd25d2cb4c	2022-01-14	Warnings	Exact identifier application applno (ANDA): 075285 application number: ANDA075285
heartburn relief	CIMETIDINE	CVS Pharmacy	464b1dec-3220-471c-b067-a06a87fb8cae	2022-01-05	Warnings	Exact identifier application applno (ANDA): 075285 application number: ANDA075285

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
197505	cimetidine 200 MG Oral Tablet	PSN	f7156440-f2d8-4292-a436-388622ff3965	3
197505	cimetidine 200 MG Oral Tablet	SCD	f7156440-f2d8-4292-a436-388622ff3965	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59640-022-72	59640002272	1 BOTTLE in 1 CARTON (59640-022-72) / 60 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2022-11-04	0000-00-00	No	No	Current