FDA.reportPublic FDA data

Famotidine

Product NDC
25021-755
11-digit product format
250210755
Labeler code
25021
Product ID
25021-755_82835fd5-d117-4b63-82c2-fe5642fc04dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
NDA219935
Marketing category
NDA
Marketing start
2025-10-15
Marketing end
2027-07-31
Substance
FAMOTIDINE
Active strength
4 mg/mL
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219935-001FAMOTIDINEFAMOTIDINE20MG/5ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-16
N219935-002FAMOTIDINEFAMOTIDINE40MG/10ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-16
N219935-003FAMOTIDINEFAMOTIDINE200MG/50ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-16

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N219935-001FAMOTIDINE20MG/5ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219935-002FAMOTIDINE40MG/10ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219935-003FAMOTIDINE200MG/50ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219935-001FAMOTIDINE20MG/5ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219935-002FAMOTIDINE40MG/10ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219935-003FAMOTIDINE200MG/50ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N219935-001FAMOTIDINE20MG/5ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219935-002FAMOTIDINE40MG/10ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219935-003FAMOTIDINE200MG/50ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-166a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219935-001FAMOTIDINE20MG/5ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219935-002FAMOTIDINE40MG/10ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219935-003FAMOTIDINE200MG/50ML (4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2025-07-16a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Famotidine

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE4 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5QZO15J2Z8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2727402Internal RxNorm lookup
2727403Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9710995d-b518-40ce-bc2b-8b5dcf002c31Available on FDA.report

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-755-05Famotidine25 in 1 CARTONINJECTION, SOLUTION255
25021-755-05Famotidine5 mL in 1 VIALINJECTION, SOLUTION55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-755-05ML - Milliliter25021-755467ce57a-9d5e-4467-9cf5-aba3c7260ab312025-12-16

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINESagent Pharmaceuticals9710995d-b518-40ce-bc2b-8b5dcf002c312026-06-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 219935
application number: NDA219935
ndc (product): 25021-755

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2727403famotidine 20 MG in 5 ML InjectionPSN9710995d-b518-40ce-bc2b-8b5dcf002c315
2727402famotidine 4 MG/ML Injectable SolutionPSN9710995d-b518-40ce-bc2b-8b5dcf002c315
27274035 ML famotidine 4 MG/ML InjectionSCD9710995d-b518-40ce-bc2b-8b5dcf002c315
2727402famotidine 4 MG/ML Injectable SolutionSCD9710995d-b518-40ce-bc2b-8b5dcf002c315
2727403famotidine 20 MG per 5 ML InjectionSY9710995d-b518-40ce-bc2b-8b5dcf002c315

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-755-052502107550525 VIAL in 1 CARTON (25021-755-05) / 5 mL in 1 VIAL25 vial2025-10-152027-07-31NoNoHistorical