Major Heartburn Relief

Product NDC: 0904-5780
11-digit product format: 009045780
Labeler code: 0904
Product ID: 0904-5780_2b99e188-08ce-4160-bf19-136bc4dd39be
Type: HUMAN OTC DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA077351
Marketing category: ANDA
Marketing start: 2006-09-29
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

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: Major Heartburn Relief
Brand name suffix: Maximum Strength
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
ee0a263e-3f78-4534-9a30-803de636f92b	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
0904-5780-17	Major Heartburn ReliefMaximum Strength	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	8
0904-5780-17	Major Heartburn ReliefMaximum Strength	25 in 1 CARTON	TABLET, FILM COATED	25	8
0904-5780-51	Major Heartburn ReliefMaximum Strength	50 in 1 BOTTLE	TABLET, FILM COATED	50	8
0904-5780-51	Major Heartburn ReliefMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5780-17	EA - Each	0904-5780	562d9b63-d2c3-4769-87e7-5ab83ee57c56	1	2012-07-24
0904-5780-51	EA - Each	0904-5780	1e29d2e4-6f3c-499a-ba10-a8de94fb1b88	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FAMOTIDINE	ACTIVE INGREDIENT	5QZO15J2Z8	MAJOR HEARTBURN RELIEF MAXIMUM STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]	3
FAMOTIDINE	ACTIVE MOIETY	5QZO15J2Z8	MAJOR HEARTBURN RELIEF MAXIMUM STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	MAJOR HEARTBURN RELIEF MAXIMUM STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MAJOR HEARTBURN RELIEF MAXIMUM STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	MAJOR HEARTBURN RELIEF MAXIMUM STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MAJOR HEARTBURN RELIEF MAXIMUM STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MAJOR HEARTBURN RELIEF MAXIMUM STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	MAJOR HEARTBURN RELIEF MAXIMUM STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	MAJOR HEARTBURN RELIEF MAXIMUM STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MAJOR HEARTBURN RELIEF MAXIMUM STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	MAJOR HEARTBURN RELIEF MAXIMUM STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MAJOR HEARTBURN RELIEF MAXIMUM STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-5780	MAJOR HEARTBURN RELIEF MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	8	Current NDC, Legacy NDC, 4 package rows	20250209_ee0a263e-3f78-4534-9a30-803de636f92b.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
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 ndc (product): 0904-5780
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	ee0a263e-3f78-4534-9a30-803de636f92b	8
310273	famotidine 20 MG Oral Tablet	SCD	ee0a263e-3f78-4534-9a30-803de636f92b	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-5780-17	00904578017	25 BLISTER PACK in 1 CARTON (0904-5780-17) / 1 TABLET, FILM COATED in 1 BLISTER PACK	25 blister pack	2006-10-04	0000-00-00	No	No	Current
0904-5780-51	00904578051	1 BOTTLE in 1 CARTON (0904-5780-51) / 50 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2006-09-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major Pharmaceuticals Heartburn Relief Drug Facts	Major Pharmaceuticals	2025-02-06	HUMAN OTC DRUG LABEL	8