FDA.reportPublic FDA data

Famotidine

Product NDC
68016-800
Requested package NDC
68016-800-30
11-digit product format
680160800
Labeler code
68016
Product ID
68016-800_b45a96e7-fbe0-e686-e75d-1629dd2cda40
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Chain Drug Consortium, LLC
Application
ANDA077367
Marketing category
ANDA
Marketing start
2021-11-01
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077367-001FAMOTIDINEFAMOTIDINE20MGTABLET / ORAL2006-09-25
A077367-002FAMOTIDINEFAMOTIDINE10MGTABLET / ORAL2001-08-17

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
2026-08-01 22:54:322026-06A077367-001FAMOTIDINE20MGTABLET / ORAL2006-09-25a50c72e98297…
2026-08-01 22:54:322026-06A077367-002FAMOTIDINE10MGTABLET / ORAL2001-08-17a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINEChain Drug Marketing Association INC7fbc5e10-30c6-7f8d-1040-d48a80fe4d792025-07-22WarningsExact identifier
application applno (ANDA): 077367
application number: ANDA077367
Acid Reducer Original StrengthFAMOTIDINEDr.Reddys Laboratories Inc.ca039876-f7e5-3e60-da5a-a1f40637a4172025-07-17WarningsExact identifier
application applno (ANDA): 077367
application number: ANDA077367
FamotidineFAMOTIDINEAlbertsons Companies27314f55-5e31-703c-b98c-ec89bf3084722025-07-17WarningsExact identifier
application applno (ANDA): 077367
application number: ANDA077367
FamotidineFAMOTIDINEFamily Dollar Stores, Inc.0f81e8ac-ddad-13d6-e883-6a5310e058de2025-07-17WarningsExact identifier
application applno (ANDA): 077367
application number: ANDA077367
FamotidineFAMOTIDINEDiscount Drug Mart, Incc5d81352-c45b-3ea1-9974-8a096bd050092025-07-17WarningsExact identifier
application applno (ANDA): 077367
application number: ANDA077367
FamotidineFAMOTIDINEChain Drug Consortium, LLC937f7bce-955b-9418-5aed-2e84aee50de32025-07-17WarningsExact identifier
application applno (ANDA): 077367
application number: ANDA077367
ndc (package): 68016-800-30
ndc (product): 68016-800
ndc11 (package): 68016080030
FamotidineFAMOTIDINEChain Drug Marketing Association INC1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a2025-07-17WarningsExact identifier
application applno (ANDA): 077367
application number: ANDA077367
FamotidineFAMOTIDINEDr.Reddys Laboratories Limited387088a6-8eaa-fc49-8050-a546d0f0fd322025-06-03WarningsExact identifier
application applno (ANDA): 077367
application number: ANDA077367

Additional Listing Data#

Finished product
Yes
Brand name base
Famotidine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE10 mg/1

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
199047Internal RxNorm lookup
310273Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
937f7bce-955b-9418-5aed-2e84aee50de3Available 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
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-800-30Famotidine30 in 1 BOTTLETABLET305
68016-800-30Famotidine1 in 1 CARTONTABLET15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-800FAMOTIDINE TABLET [CHAIN DRUG CONSORTIUM, LLC]4Current NDC, Legacy NDC, 2 package rows20241024_937f7bce-955b-9418-5aed-2e84aee50de3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN937f7bce-955b-9418-5aed-2e84aee50de35
310273famotidine 20 MG Oral TabletPSN937f7bce-955b-9418-5aed-2e84aee50de35
199047famotidine 10 MG Oral TabletSCD937f7bce-955b-9418-5aed-2e84aee50de35
310273famotidine 20 MG Oral TabletSCD937f7bce-955b-9418-5aed-2e84aee50de35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-800-30680160800301 BOTTLE in 1 CARTON (68016-800-30) / 30 TABLET in 1 BOTTLE1 bottle2021-11-010000-00-00NoNoCurrent