FDA.reportPublic FDA data

Famotidine

Product NDC
70860-751
11-digit product format
708600751
Labeler code
70860
Product ID
70860-751_2cc9707d-b7b9-36ec-e063-6294a90a1e44
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
famotidine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Athenex Pharmaceutical Division, LLC.
Application
ANDA075622
Marketing category
ANDA
Marketing start
2020-08-10
Marketing end
2026-07-31
Substance
FAMOTIDINE
Active strength
10 mg/mL
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Famotidine

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui204441, 1743833

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcaeProduct name720260317
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
cf645750-2e70-f6e1-c05a-a52847def5ddProduct name920250312
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70860-751-022024-03-03C16284748780-11030e364-fdf0-111a-e063-dadaa90a10e2Famotidine Injection, USP
70860-751-022024-01-30C16284748780-11030e364-fdf0-111a-e063-dadaa90a10e2Famotidine Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70860-751-02Famotidine25 in 1 CARTONINJECTION, SOLUTION255
70860-751-41Famotidine2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70860-751-02ML - Milliliter70860-75196e7acb3-a44a-40e4-a071-c36d5963190512021-01-08
70860-751-41ML - Milliliter70860-751bed63e24-a456-4e67-83ab-2b70d1a87c3d12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70860-751FAMOTIDINE INJECTION, SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.]5Current NDC, Legacy NDC, 2 package rows20250130_234d941f-5754-4d83-b02e-26638e0054e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204441famotidine 10 MG/ML Injectable SolutionPSN234d941f-5754-4d83-b02e-26638e0054e65
1743833famotidine 20 MG in 2 ML InjectionPSN234d941f-5754-4d83-b02e-26638e0054e65
17438332 ML famotidine 10 MG/ML InjectionSCD234d941f-5754-4d83-b02e-26638e0054e65
204441famotidine 10 MG/ML Injectable SolutionSCD234d941f-5754-4d83-b02e-26638e0054e65
1743833famotidine 20 MG per 2 ML InjectionSY234d941f-5754-4d83-b02e-26638e0054e65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70860-751-027086007510225 VIAL, SINGLE-DOSE in 1 CARTON (70860-751-02) / 2 mL in 1 VIAL, SINGLE-DOSE (70860-751-41) 2020-08-102026-07-31NoNoCurrent
70860-751-41708600751412 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical