TopCare Acid Reducer

Product NDC: 36800-194
11-digit product format: 368000194
Labeler code: 36800
Product ID: 36800-194_4f159fc7-8379-465d-9a92-d3c8bffefdc6
Type: HUMAN OTC DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Topco Associates LLC
Application: ANDA077351
Marketing category: ANDA
Marketing start: 2006-09-28
Substance: FAMOTIDINE
Active strength: 20 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

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	36800-194	36800-194-51	D	Discontinued by firm		2026-10-12

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 · 12 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…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077351-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL			2006-09-25

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: TopCare Acid Reducer
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FAMOTIDINE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5QZO15J2Z8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310273	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
c3c9ae86-f6d7-4a6c-a991-be8ef7c6adbe	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcae	Product name	7	20260317
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
cf645750-2e70-f6e1-c05a-a52847def5dd	Product name	9	20250312
4fdc761c-585e-054b-8ebe-86130a26e4c1	Product name	2	20221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
36800-194-02	TopCare Acid Reducer	25 in 1 CARTON	TABLET, FILM COATED	25	10
36800-194-02	TopCare Acid Reducer	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	10
36800-194-51	TopCare Acid Reducer	8 in 1 CARTON	TABLET, FILM COATED	8	10
36800-194-51	TopCare Acid Reducer	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	10
36800-194-71	TopCare Acid Reducer	1 in 1 CARTON	TABLET, FILM COATED	1	10
36800-194-71	TopCare Acid Reducer	50 in 1 BOTTLE	TABLET, FILM COATED	50	10
36800-194-78	TopCare Acid Reducer	100 in 1 BOTTLE	TABLET, FILM COATED	100	10
36800-194-78	TopCare Acid Reducer	1 in 1 CARTON	TABLET, FILM COATED	1	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-194-02	EA - Each	36800-194	75c9ce75-84e0-416b-b14a-c23c729244e8	1	2012-07-24
36800-194-51	EA - Each	36800-194	765da51c-8260-4626-bf2b-60a661d99ba1	1	2012-07-24
36800-194-71	EA - Each	36800-194	e4a245ca-3397-4319-9ca7-af7aeb3e9a6e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
FAMOTIDINE	ACTIVE INGREDIENT	5QZO15J2Z8	TOPCARE ACID REDUCER (FAMOTIDINE) TABLET [TOPCO ASSOCIATES LLC]	1
FAMOTIDINE	ACTIVE MOIETY	5QZO15J2Z8	TOPCARE ACID REDUCER (FAMOTIDINE) TABLET [TOPCO ASSOCIATES LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-194	TOPCARE ACID REDUCER (FAMOTIDINE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]	9	Current NDC, Legacy NDC, 8 package rows	20250213_c3c9ae86-f6d7-4a6c-a991-be8ef7c6adbe.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 2 of 2 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Acid Reducer	FAMOTIDINE	Cardinal Health 110, LLC. dba Leader	321b83f9-4bbf-494a-9279-80b0742049b6	2025-08-21	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
foster and thrive acid reducer	FAMOTIDINE	Strategic Sourcing Services LLC	0c480ba4-b07e-4109-a9a9-5480b4a39a1d	2025-08-21	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
members mark acid pep	FAMOTIDINE	Sam's West Inc	f9f4a91c-60a2-4893-88e6-639d24237375	2025-08-21	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
TopCare Acid Reducer	FAMOTIDINE	Topco Associates LLC	c3c9ae86-f6d7-4a6c-a991-be8ef7c6adbe	2025-08-15	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351 ndc (product): 36800-194
Rugby Famotidine	FAMOTIDINE	Rugby Laboratories	cdb6caa5-5be6-4597-a930-b8c816ac3040	2025-08-13	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
acid controller	FAMOTIDINE	Safeway	f3d08f06-a676-43b0-8f77-611f0af737a7	2025-08-07	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
equate famotidine	FAMOTIDINE	WALMART INC.	f38f8a8f-3292-4fe5-b83f-ffd634196d42	2025-07-16	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
Famotidine	FAMOTIDINE	Precision Dose, Inc.	de42b6c4-c44b-4ec1-b505-fc5266452d57	2025-05-27	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
acid reducer	FAMOTIDINE	CVS Pharmacy	373f5e28-e9e2-4af7-8a27-29b5d8f28b50	2025-04-07	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
heartburn relief	FAMOTIDINE	Meijer Distribution Inc	263ee489-fc3f-4578-b3a5-44f6d7757898	2025-02-13	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
kirkland signature acid controller	FAMOTIDINE	Costco Wholesale Company	d5d96078-ba87-4593-b15b-b7a646a8ab10	2025-02-12	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
Acid Controller	FAMOTIDINE	H E B	cbe72270-b172-4662-9b9b-557e8cf53ffe	2025-02-11	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
basic care acid reducer	FAMOTIDINE	Amazon.com Services LLC	0983cef7-b8b6-4ed9-a01e-c699fa6d2d06	2025-02-10	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
Major Heartburn Relief Maximum Strength	FAMOTIDINE	Major Pharmaceuticals	ee0a263e-3f78-4534-9a30-803de636f92b	2025-02-06	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
dg health heartburn prevention	FAMOTIDINE	Dolgencorp Inc	679cdecb-9e25-4f43-b4f4-7f5f3fbf2296	2024-11-11	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
topcare acid reducer	FAMOTIDINE	Topco Associates LLC	7824fdab-cdd5-457d-9b14-b82b19ea9529	2022-10-03	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
dg health acid reducer	FAMOTIDINE	Dolgencorp Inc	3ffa405e-bc85-4614-afd0-7a8dfc288dad	2022-07-13	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
dg health heartburn prevention	FAMOTIDINE	Dolgencorp Inc	a8383769-ce8b-43eb-b1a6-5d73e7fcf30d	2022-06-07	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
basic care acid reducer	FAMOTIDINE	Amazon.com Services LLC	94fbcebe-7d75-47c1-9eca-cfa9b952a3d5	2022-01-06	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5QZO15J2Z8	FAMOTIDINE	76824-35-6	FAMOTIDINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310273	famotidine 20 MG Oral Tablet	PSN	c3c9ae86-f6d7-4a6c-a991-be8ef7c6adbe	10
310273	famotidine 20 MG Oral Tablet	SCD	c3c9ae86-f6d7-4a6c-a991-be8ef7c6adbe	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-194-02	36800019402	25 BLISTER PACK in 1 CARTON (36800-194-02) / 1 TABLET, FILM COATED in 1 BLISTER PACK	25 blister pack	2006-09-28	0000-00-00	No	No	Current
36800-194-51	36800019451	8 BLISTER PACK in 1 CARTON (36800-194-51) > 1 TABLET, FILM COATED in 1 BLISTER PACK	8 blister pack	2006-10-16	0000-00-00	No	No	Current
36800-194-71	36800019471	1 BOTTLE in 1 CARTON (36800-194-71) / 50 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2006-10-16	0000-00-00	No	No	Current
36800-194-78	36800019478	1 BOTTLE in 1 CARTON (36800-194-78) / 100 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2021-02-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Acid Reducer Drug Facts	Topco Associates LLC	2025-08-15	HUMAN OTC DRUG LABEL	10