Famotidine Tablets, USP

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-30
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 21:18:24

Label at a glance#

ProductFamotidine

Active ingredientFAMOTIDINE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1702-3

Famotidine Tablets USP, 20 mg

30 Tablets

Rx only

NDC 70771-1703-3

Famotidine Tablets USP, 40 mg

30 Tablets

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310273	famotidine 20 MG Oral Tablet	PSN	3
284245	famotidine 40 MG Oral Tablet	PSN	3
310273	famotidine 20 MG Oral Tablet	SCD	3
284245	famotidine 40 MG Oral Tablet	SCD	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
FAMOTIDINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

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
70771-1702-0	Famotidine	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	3
70771-1702-1	Famotidine	100 in 1 BOTTLE	TABLET, FILM COATED	100	3
70771-1702-2	Famotidine	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	3
70771-1702-3	Famotidine	30 in 1 BOTTLE	TABLET, FILM COATED	30	3
70771-1702-4	Famotidine	10 in 1 CARTON	TABLET, FILM COATED	10	3
70771-1702-5	Famotidine	500 in 1 BOTTLE	TABLET, FILM COATED	500	3
70771-1703-0	Famotidine	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	3
70771-1703-1	Famotidine	100 in 1 BOTTLE	TABLET, FILM COATED	100	3
70771-1703-2	Famotidine	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	3
70771-1703-3	Famotidine	30 in 1 BOTTLE	TABLET, FILM COATED	30	3
70771-1703-4	Famotidine	10 in 1 CARTON	TABLET, FILM COATED	10	3
70771-1703-5	Famotidine	500 in 1 BOTTLE	TABLET, FILM COATED	500	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1702	FAMOTIDINE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	3	Current NDC, Legacy NDC, 6 package rows	20241201_8c17f9e3-9827-4bf9-85ca-72e08a8518ca.zip
70771-1703	FAMOTIDINE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	3	Current NDC, Legacy NDC, 6 package rows	20241201_8c17f9e3-9827-4bf9-85ca-72e08a8518ca.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Famotidine
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 101
MICROCRYSTALLINE CELLULOSE 102
POLYETHYLENE GLYCOL 8000
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A
STARCH, CORN
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1702	70771-1702-3, 70771-1702-1, 70771-1702-5, 70771-1702-0, 70771-1702-2, 70771-1702-4
70771-1703	70771-1703-3, 70771-1703-1, 70771-1703-5, 70771-1703-2, 70771-1703-4, 70771-1703-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FAMOTIDINE	5QZO15J2Z8	ACTIB
HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE 101	7T9FYH5QMK	IACT
MICROCRYSTALLINE CELLULOSE 102	PNR0YF693Y	IACT
POLYETHYLENE GLYCOL 8000	Q662QK8M3B	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM STARCH GLYCOLATE TYPE A	H8AV0SQX4D	IACT
STARCH, CORN	O8232NY3SJ	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FAMOTIDINE	5QZO15J2Z8	ACTIB
HYPROMELLOSE 2910 (5 MPA.S)	R75537T0T4	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE 101	7T9FYH5QMK	IACT
MICROCRYSTALLINE CELLULOSE 102	PNR0YF693Y	IACT
POLYETHYLENE GLYCOL 8000	Q662QK8M3B	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM STARCH GLYCOLATE TYPE A	H8AV0SQX4D	IACT
STARCH, CORN	O8232NY3SJ	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A216441-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL	AB		2022-06-03
A216441-002	FAMOTIDINE	FAMOTIDINE	40MG	TABLET / ORAL	AB		2022-06-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A216441-001	AB
A216441-002	AB

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 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216441-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-06-03	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216441-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-06-03	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A216441-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A216441-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A216441-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216441-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216441-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216441-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216441-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216441-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216441-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216441-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216441-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216441-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216441-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216441-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216441-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216441-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216441-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216441-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216441-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216441-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216441-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216441-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216441-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216441-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216441-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216441-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216441-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216441-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216441-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216441-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216441-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216441-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216441-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216441-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216441-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A216441-002	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216441-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216441-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216441-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216441-002	AB	1	`1c564ffb4f44…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Zydus Lifesciences Limited	8c17f9e3-9827-4bf9-85ca-72e08a8518ca	2024-11-30		Exact identifier ndc (package): 70771-1703-0 ndc (package): 70771-1703-5 ndc (package): 70771-1702-0 ndc (package): 70771-1703-2 ndc (package): 70771-1703-1 ndc (package): 70771-1703-3 ndc (package): 70771-1702-4 ndc (package): 70771-1702-2 ndc (package): 70771-1702-5 ndc (package): 70771-1702-3 ndc (package): 70771-1702-1 ndc (package): 70771-1703-4 ndc (product): 70771-1702 ndc (product): 70771-1703 ndc11 (package): 70771170204 ndc11 (package): 70771170305 ndc11 (package): 70771170302 ndc11 (package): 70771170303 ndc11 (package): 70771170300 ndc11 (package): 70771170301 ndc11 (package): 70771170203 ndc11 (package): 70771170200 ndc11 (package): 70771170201 ndc11 (package): 70771170202 ndc11 (package): 70771170205 ndc11 (package): 70771170304 spl id: 33e9f14f-e971-4fbb-9912-991661ae4d05 spl set id: 8c17f9e3-9827-4bf9-85ca-72e08a8518ca

Reported adverse events (FAERS/openFDA)#

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