Famotidine 10 mg

Product NDC: 25000-086
11-digit product format: 250000086
Labeler code: 25000
Product ID: 25000-086_c1fe0ae2-1d7b-409d-97cb-9e03eeb7f402
Type: HUMAN OTC DRUG
Nonproprietary name: Famotidine 10 mg
Dosage form: TABLET, COATED
Route: ORAL
Labeler: MARKSANS PHARMA LIMITED
Application: ANDA217543
Marketing category: ANDA
Marketing start: 2023-03-10
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217543-001	FAMOTIDINE	FAMOTIDINE	10MG	TABLET / ORAL			2023-03-08
A217543-002	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL			2023-03-08

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 · 46 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	A217543-001	FAMOTIDINE	10MG	TABLET / ORAL	2023-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217543-002	FAMOTIDINE	20MG	TABLET / ORAL	2023-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217543-001	FAMOTIDINE	10MG	TABLET / ORAL	2023-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217543-002	FAMOTIDINE	20MG	TABLET / ORAL	2023-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217543-001	FAMOTIDINE	10MG	TABLET / ORAL	2023-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217543-002	FAMOTIDINE	20MG	TABLET / ORAL	2023-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217543-001	FAMOTIDINE	10MG	TABLET / ORAL	2023-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217543-002	FAMOTIDINE	20MG	TABLET / ORAL	2023-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217543-001	FAMOTIDINE	10MG	TABLET / ORAL	2023-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217543-002	FAMOTIDINE	20MG	TABLET / ORAL	2023-03-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217543-001	FAMOTIDINE	10MG	TABLET / ORAL	2023-03-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217543-002	FAMOTIDINE	20MG	TABLET / ORAL	2023-03-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217543-001	FAMOTIDINE	10MG	TABLET / ORAL	2023-03-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217543-002	FAMOTIDINE	20MG	TABLET / ORAL	2023-03-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217543-001	FAMOTIDINE	10MG	TABLET / ORAL	2023-03-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217543-002	FAMOTIDINE	20MG	TABLET / ORAL	2023-03-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217543-001	FAMOTIDINE	10MG	TABLET / ORAL	2023-03-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217543-002	FAMOTIDINE	20MG	TABLET / ORAL	2023-03-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217543-001	FAMOTIDINE	10MG	TABLET / ORAL	2023-03-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217543-002	FAMOTIDINE	20MG	TABLET / ORAL	2023-03-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217543-001	FAMOTIDINE	10MG	TABLET / ORAL	2023-03-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217543-002	FAMOTIDINE	20MG	TABLET / ORAL	2023-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217543-001	FAMOTIDINE	10MG	TABLET / ORAL	2023-03-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217543-002	FAMOTIDINE	20MG	TABLET / ORAL	2023-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217543-001	FAMOTIDINE	10MG	TABLET / ORAL	2023-03-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217543-002	FAMOTIDINE	20MG	TABLET / ORAL	2023-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217543-001	FAMOTIDINE	10MG	TABLET / ORAL	2023-03-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217543-002	FAMOTIDINE	20MG	TABLET / ORAL	2023-03-08	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217543-001	FAMOTIDINE	10MG	TABLET / ORAL	2023-03-08	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217543-002	FAMOTIDINE	20MG	TABLET / ORAL	2023-03-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217543-001	FAMOTIDINE	10MG	TABLET / ORAL	2023-03-08	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217543-002	FAMOTIDINE	20MG	TABLET / ORAL	2023-03-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217543-001	FAMOTIDINE	10MG	TABLET / ORAL	2023-03-08	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217543-002	FAMOTIDINE	20MG	TABLET / ORAL	2023-03-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217543-001	FAMOTIDINE	10MG	TABLET / ORAL	2023-03-08	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217543-002	FAMOTIDINE	20MG	TABLET / ORAL	2023-03-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217543-001	FAMOTIDINE	10MG	TABLET / ORAL	2023-03-08	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217543-002	FAMOTIDINE	20MG	TABLET / ORAL	2023-03-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217543-001	FAMOTIDINE	10MG	TABLET / ORAL	2023-03-08	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217543-002	FAMOTIDINE	20MG	TABLET / ORAL	2023-03-08	`a67488948f0b…`

Additional Listing Data#

Finished product: Yes
Brand name base: Famotidine 10 mg
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199047	Internal RxNorm lookup
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
58b653eb-6539-4b79-9d22-df6eaf35307f	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
25000-086-03	Famotidine 10 mg	30 in 1 BOTTLE	TABLET, COATED	30	5
25000-086-03	Famotidine 10 mg	1 in 1 CARTON	TABLET, COATED	1	5
25000-086-07	Famotidine 10 mg	90 in 1 BOTTLE	TABLET, COATED	90	5
25000-086-07	Famotidine 10 mg	1 in 1 CARTON	TABLET, COATED	1	5
25000-086-08	Famotidine 10 mg	1 in 1 CARTON	TABLET, COATED	1	5
25000-086-08	Famotidine 10 mg	100 in 1 BOTTLE	TABLET, COATED	100	5
25000-086-36	Famotidine 10 mg	3 in 1 CARTON	TABLET, COATED	3	5
25000-086-36	Famotidine 10 mg	10 in 1 BLISTER PACK	TABLET, COATED	10	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25000-086	FAMOTIDINE 10 MG TABLET, COATED FAMOTIDINE 20 MG TABLET, COATED [MARKSANS PHARMA LIMITED]	5	Current NDC, 8 package rows	20250325_58b653eb-6539-4b79-9d22-df6eaf35307f.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
Famotidine 20 mg	FAMOTIDINE 20 MG	MARKSANS PHARMA LIMITED	5a66206b-35b1-4d86-8574-a1e45cb0772f	2025-05-06	Warnings	Exact identifier application applno (ANDA): 217543 application number: ANDA217543
Famotidine 10 mg	FAMOTIDINE 10 MG	MARKSANS PHARMA LIMITED	58b653eb-6539-4b79-9d22-df6eaf35307f	2024-09-30	Warnings	Exact identifier application applno (ANDA): 217543 application number: ANDA217543 ndc (product): 25000-086
Original strength heartburn prevention	FAMOTIDINE	KROGER COMPANY	ea1c2838-acbd-18e0-e053-2a95a90a3522	2024-07-08	Warnings	Exact identifier application applno (ANDA): 217543 application number: ANDA217543
Maximum Strength Acid Reducer	FAMOTIDINE	TARGET CORPORATION	07a924f1-14cc-4e7d-e063-6394a90ac7f3	2024-05-13	Warnings	Exact identifier application applno (ANDA): 217543 application number: ANDA217543
Maximum Strength Acid Reducer	FAMOTIDINE	TIME CAP LABORATORIES,INC	fe25e1e2-7158-6fe0-e053-6394a90a3bb1	2024-03-06	Warnings	Exact identifier application applno (ANDA): 217543 application number: ANDA217543
Maximum Strength Acid Controller	FAMOTIDINE	BETTER LIVING BRANDS LLC.	f2c031b4-de86-3a8e-e053-2a95a90a21e0	2023-07-30	Warnings	Exact identifier application applno (ANDA): 217543 application number: ANDA217543

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	58b653eb-6539-4b79-9d22-df6eaf35307f	5
310273	famotidine 20 MG Oral Tablet	PSN	58b653eb-6539-4b79-9d22-df6eaf35307f	5
199047	famotidine 10 MG Oral Tablet	SCD	58b653eb-6539-4b79-9d22-df6eaf35307f	5
310273	famotidine 20 MG Oral Tablet	SCD	58b653eb-6539-4b79-9d22-df6eaf35307f	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
25000-086-03	25000008603	1 BOTTLE in 1 CARTON (25000-086-03) / 30 TABLET, COATED in 1 BOTTLE	1 bottle	2023-03-10	No	No	Current
25000-086-07	25000008607	1 BOTTLE in 1 CARTON (25000-086-07) / 90 TABLET, COATED in 1 BOTTLE	1 bottle	2024-04-24	No	No	Current
25000-086-08	25000008608	1 BOTTLE in 1 CARTON (25000-086-08) / 100 TABLET, COATED in 1 BOTTLE	1 bottle	2023-03-10	No	No	Current
25000-086-36	25000008636	3 BLISTER PACK in 1 CARTON (25000-086-36) / 10 TABLET, COATED in 1 BLISTER PACK	3 blister pack	2023-03-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Famotidine Tablets USP, 10 mg and 20 mg	MARKSANS PHARMA LIMITED	2024-09-30	Human OTC Drug Label	5