heartburn relief

Product NDC: 63187-999
11-digit product format: 631870999
Labeler code: 63187
Product ID: 63187-999_6df77a1c-accd-4559-9a9a-00a030f6ba64
Type: HUMAN OTC DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA075400
Marketing category: ANDA
Marketing start: 2009-09-09
Substance: FAMOTIDINE
Active strength: 10 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
A075400-001	FAMOTIDINE	FAMOTIDINE	10MG	TABLET / ORAL			2005-03-18

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	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075400-001	FAMOTIDINE	10MG	TABLET / ORAL	2005-03-18	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: heartburn relief
Brand name suffix: original strength
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FAMOTIDINE	10 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
199047	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
5567aaaf-b4f2-4604-b841-c9447e77256c	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
63187-999-10	heartburn relieforiginal strength	10 in 1 BOTTLE	TABLET	10	3
63187-999-30	heartburn relieforiginal strength	30 in 1 BOTTLE	TABLET	30	3
63187-999-60	heartburn relieforiginal strength	60 in 1 BOTTLE	TABLET	60	3
63187-999-90	heartburn relieforiginal strength	90 in 1 BOTTLE	TABLET	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-999-30	EA - Each	63187-999	b1c97804-5d51-493d-9ae8-d009d55116a2	1	2018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-999	HEARTBURN RELIEF ORIGINAL STRENGTH (FAMOTIDINE) TABLET [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 4 package rows	20191122_5567aaaf-b4f2-4604-b841-c9447e77256c.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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CareOne Acid Relief	FAMOTIDINE	American Sales Company	ed474c9d-c08b-4f52-8b24-5887978e4275	2026-07-01	Warnings	Exact identifier application applno (ANDA): 075400 application number: ANDA075400
acid relief	FAMOTIDINE	Rite Aid Corporation	9826dd26-5592-4f96-9274-005ef9462cb4	2026-05-27	Warnings	Exact identifier application applno (ANDA): 075400 application number: ANDA075400
good sense acid reducer	FAMOTIDINE	L. Perrigo Company	cc77f6ff-a534-4731-b971-491280840899	2026-05-18	Warnings	Exact identifier application applno (ANDA): 075400 application number: ANDA075400
acid reducer original strength	FAMOTIDINE	HyVee Inc	a0f2683f-59ad-4f65-a108-696430d577ab	2026-03-16	Warnings	Exact identifier application applno (ANDA): 075400 application number: ANDA075400
Acid Controller Original Strength	FAMOTIDINE	Walgreen Company	98c6ddc9-8103-40b3-a145-ffbe3374ab6c	2026-03-03	Warnings	Exact identifier application applno (ANDA): 075400 application number: ANDA075400
heartburn relief original strength	FAMOTIDINE	Major Pharmaceuticals	be275c48-18bf-45f6-891d-36d89327813e	2026-02-13	Warnings	Exact identifier application applno (ANDA): 075400 application number: ANDA075400
ACID CONTROLLER	FAMOTIDINE	Safeway	9ddfb9fd-1b84-4e9a-90b5-6a3362d345dd	2025-08-13	Warnings	Exact identifier application applno (ANDA): 075400 application number: ANDA075400
acid controller	FAMOTIDINE	H E B	813d742f-8f3d-4f18-a6c5-03eea946f976	2025-06-23	Warnings	Exact identifier application applno (ANDA): 075400 application number: ANDA075400
TopCare Acid Reducer	FAMOTIDINE	Topco Associates LLC	88722f84-dac8-4130-93b3-9e0dc1cc5acc	2025-06-13	Warnings	Exact identifier application applno (ANDA): 075400 application number: ANDA075400
heartburn relief	FAMOTIDINE	Meijer Distribution Inc	05c03fd8-abc8-47f7-868c-895b9a38c5b3	2025-02-17	Warnings	Exact identifier application applno (ANDA): 075400 application number: ANDA075400
acid reducer	FAMOTIDINE	Publix Super Markets Inc	a3ba9983-6747-45b2-b270-4ac1fb9d6e40	2025-02-17	Warnings	Exact identifier application applno (ANDA): 075400 application number: ANDA075400
acid controller original strength	FAMOTIDINE	CVS Pharmacy	c7cb4e19-3442-45d2-b60a-87d4beea862a	2025-02-13	Warnings	Exact identifier application applno (ANDA): 075400 application number: ANDA075400
dg health heartburn prevention original strength	FAMOTIDINE	Dolgencorp, LLC	f5c0ff75-77da-443c-a510-9c6a065ddc6c	2025-02-11	Warnings	Exact identifier application applno (ANDA): 075400 application number: ANDA075400
foster and thrive acid reducer	FAMOTIDINE	Strategic Sourcing Services LLC	9ff8539f-cdcd-4823-8baa-10a249c9220d	2025-02-10	Warnings	Exact identifier application applno (ANDA): 075400 application number: ANDA075400
basic care acid reducer	FAMOTIDINE	Amazon.com Services LLC	52e3b2f5-f3b9-4f4e-a70f-322eb04e6e8a	2025-02-10	Warnings	Exact identifier application applno (ANDA): 075400 application number: ANDA075400
signature care acid controller	FAMOTIDINE	Safeway	adbf2c58-cd1c-4444-b133-21a18a348931	2025-02-10	Warnings	Exact identifier application applno (ANDA): 075400 application number: ANDA075400
equaline heartburn prevention	FAMOTIDINE	United Natural Foods, Inc. dba UNFI	4b78d0c8-7d0c-45e6-9b36-b248f002f2b8	2025-02-10	Warnings	Exact identifier application applno (ANDA): 075400 application number: ANDA075400
Equate Famotidine	FAMOTIDINE	Wal-Mart Stores Inc	15973213-0e11-4d18-b437-50b0a593cb7b	2025-02-06	Warnings	Exact identifier application applno (ANDA): 075400 application number: ANDA075400
heartburn relief original strength	FAMOTIDINE	Proficient Rx LP	5567aaaf-b4f2-4604-b841-c9447e77256c	2019-10-01	Warnings	Exact identifier application applno (ANDA): 075400 application number: ANDA075400 ndc (product): 63187-999

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
199047	famotidine 10 MG Oral Tablet	PSN	5567aaaf-b4f2-4604-b841-c9447e77256c	3
199047	famotidine 10 MG Oral Tablet	SCD	5567aaaf-b4f2-4604-b841-c9447e77256c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-999-10	63187099910	10 TABLET in 1 BOTTLE (63187-999-10)	10 tablet	2018-04-02	0000-00-00	No	No	Current
63187-999-30	63187099930	30 TABLET in 1 BOTTLE (63187-999-30)	30 tablet	2018-04-02	0000-00-00	No	No	Current
63187-999-60	63187099960	60 TABLET in 1 BOTTLE (63187-999-60)	60 tablet	2018-04-02	0000-00-00	No	No	Current
63187-999-90	63187099990	90 TABLET in 1 BOTTLE (63187-999-90)	90 tablet	2018-04-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major Pharmaceuticals Heartburn Relief Drug Facts	Proficient Rx LP	2019-10-01	HUMAN OTC DRUG LABEL	3