Famotidine

Manufacturer: Cantrell Drug Company
Effective date: 2014-06-16
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 20:18:53

Label at a glance#

ProductFamotidine

Active ingredientFAMOTIDINE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Data Matrix	01003525331721201710		52533-172-12.jpg

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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52533-172-12	2019-11-27	C162847	48780-1	9855e2a2-39fc-60a7-e053-dbdaa90a05bd	Famotidine 2 mg/mL in 0.9% Sodium Chloride 10 mL Syringe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52533-172-12	Famotidine	10 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	10		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52533-172	FAMOTIDINE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	3	Legacy NDC, 1 package rows	20140616_36a915cd-75ae-40b8-b174-026d49ea23d7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
FAMOTIDINE	ACTIVE INGREDIENT	5QZO15J2Z8	3
FAMOTIDINE	ACTIVE MOIETY	5QZO15J2Z8	3
ASPARTIC ACID	INACTIVE INGREDIENT	30KYC7MIAI	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Famotidine
SODIUM CHLORIDE
MANNITOL
ASPARTIC ACID
WATER
HYDROCHLORIC ACID
SODIUM HYDROXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52533-172	52533-172-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FAMOTIDINE	5QZO15J2Z8	ACTIB
SODIUM CHLORIDE	451W47IQ8X	IACT
MANNITOL	3OWL53L36A	IACT
ASPARTIC ACID	30KYC7MIAI	IACT
WATER	059QF0KO0R	IACT
HYDROCHLORIC ACID	QTT17582CB	CNTM
SODIUM HYDROXIDE	55X04QC32I	CNTM

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 200 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBMUCOSAL	16 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / EPIDURAL		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAVITREAL		6 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOAP / TOPICAL	1.26 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / AURICULAR (OTIC)	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE, COATED PELLETS / ORAL		14 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION / INTRAMUSCULAR	106.6 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRA-ARTERIAL		278 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ENDOTRACHEAL	7.6 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	35 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION / INTRAVENOUS		15400 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER / ORAL		4352 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	IMPLANT / SUBCUTANEOUS	77 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, SUSPENSION / INTRAVENOUS	2.5 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER, FOR SOLUTION / ORAL		3767 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET / ORAL		231 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	GRANULE / ORAL		1328 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / IONTOPHORESIS	0.6 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAMUSCULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / SUBCUTANEOUS	0.8 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SUSPENSION / OPHTHALMIC		9 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER / RESPIRATORY (INHALATION)		6 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		2922 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INHALANT / RESPIRATORY (INHALATION)	3 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SUSPENSION/ DROPS / OPHTHALMIC	3.3 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER, FOR SUSPENSION / INTRAMUSCULAR	6.75 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, EXTENDED RELEASE / ORAL	335.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / EPIDURAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GEL / VAGINAL	10 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SOLUTION / PARENTERAL	200 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, DELAYED RELEASE / ORAL		97 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER / TOPICAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		543 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TROCHE / ORAL		14594 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	ENEMA / RECTAL	0.7 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, COATED / ORAL	54.7 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SHAMPOO / TOPICAL		150 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL		11 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		15400 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRASYNOVIAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / INTRAMUSCULAR	9 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	WAFER / ORAL	642 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVENOUS		28773 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / OPHTHALMIC		3 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRASYNOVIAL		4 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION, GEL FORMING / DROPS / OPHTHALMIC		4 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		360 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ORAL		1126 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	ELIXIR / ORAL	1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / TOPICAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRATHECAL		9 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		105 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	0.68 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / TOPICAL	0.23 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates

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
24f07811-6f00-4d0c-8fe1-74ffbc17e404			36a915cd-75ae-40b8-b174-026d49ea23d7	2014-06-16		Exact identifier spl id: 24f07811-6f00-4d0c-8fe1-74ffbc17e404 spl set id: 36a915cd-75ae-40b8-b174-026d49ea23d7

Reported adverse events (FAERS/openFDA)#

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