Famotidine

Product NDC
55111-118
Requested package NDC
55111-118-98
11-digit product format
551110118
Labeler code
55111
Product ID
55111-118_e818465f-a1ca-0e6a-f18c-cf2cb2a2cc82
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Dr.Reddys Laboratories Limited
Application
ANDA077367
Marketing category
ANDA
Marketing start
2006-09-30
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage55111-11855111-118-98UNFINISHEDActive or certified unfinished drug listing2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-276db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-188fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-174184dd79f89f…545327b3e20f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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.

Product history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077367-001FAMOTIDINE20MGTABLET / ORAL2006-09-25caaa826d4ba7…
2026-08-18 06:07:402026-07A077367-002FAMOTIDINE10MGTABLET / ORAL2001-08-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077367-001FAMOTIDINE20MGTABLET / ORAL2006-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077367-002FAMOTIDINE10MGTABLET / ORAL2001-08-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077367-001FAMOTIDINE20MGTABLET / ORAL2006-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077367-002FAMOTIDINE10MGTABLET / ORAL2001-08-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077367-001FAMOTIDINE20MGTABLET / ORAL2006-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077367-002FAMOTIDINE10MGTABLET / ORAL2001-08-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077367-001FAMOTIDINE20MGTABLET / ORAL2006-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077367-002FAMOTIDINE10MGTABLET / ORAL2001-08-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077367-001FAMOTIDINE20MGTABLET / ORAL2006-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077367-002FAMOTIDINE10MGTABLET / ORAL2001-08-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077367-001FAMOTIDINE20MGTABLET / ORAL2006-09-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077367-002FAMOTIDINE10MGTABLET / ORAL2001-08-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077367-001FAMOTIDINE20MGTABLET / ORAL2006-09-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077367-002FAMOTIDINE10MGTABLET / ORAL2001-08-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077367-001FAMOTIDINE20MGTABLET / ORAL2006-09-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077367-002FAMOTIDINE10MGTABLET / ORAL2001-08-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077367-001FAMOTIDINE20MGTABLET / ORAL2006-09-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077367-002FAMOTIDINE10MGTABLET / ORAL2001-08-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077367-001FAMOTIDINE20MGTABLET / ORAL2006-09-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A077367-002FAMOTIDINE10MGTABLET / ORAL2001-08-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077367-001FAMOTIDINE20MGTABLET / ORAL2006-09-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077367-002FAMOTIDINE10MGTABLET / ORAL2001-08-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077367-001FAMOTIDINE20MGTABLET / ORAL2006-09-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077367-002FAMOTIDINE10MGTABLET / ORAL2001-08-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077367-001FAMOTIDINE20MGTABLET / ORAL2006-09-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077367-002FAMOTIDINE10MGTABLET / ORAL2001-08-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077367-001FAMOTIDINE20MGTABLET / ORAL2006-09-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077367-002FAMOTIDINE10MGTABLET / ORAL2001-08-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077367-001FAMOTIDINE20MGTABLET / ORAL2006-09-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077367-002FAMOTIDINE10MGTABLET / ORAL2001-08-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077367-001FAMOTIDINE20MGTABLET / ORAL2006-09-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077367-002FAMOTIDINE10MGTABLET / ORAL2001-08-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077367-001FAMOTIDINE20MGTABLET / ORAL2006-09-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077367-002FAMOTIDINE10MGTABLET / ORAL2001-08-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077367-001FAMOTIDINE20MGTABLET / ORAL2006-09-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077367-001FAMOTIDINE20MGTABLET / ORAL2006-09-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077367-002FAMOTIDINE10MGTABLET / ORAL2001-08-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077367-001FAMOTIDINE20MGTABLET / ORAL2006-09-25782e0a99824c…

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
387088a6-8eaa-fc49-8050-a546d0f0fd32Available 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-118-90EA - Each55111-118b0358378-0ed2-4912-b058-89e7e6d918f712021-04-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]3
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AFAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]3
TALCINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]3
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET [WAL-MART STORES INC]2
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET [WAL-MART STORES INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET [WAL-MART STORES INC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FAMOTIDINE TABLET [WAL-MART STORES INC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFAMOTIDINE TABLET [WAL-MART STORES INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET [WAL-MART STORES INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFAMOTIDINE TABLET [WAL-MART STORES INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FAMOTIDINE TABLET [WAL-MART STORES INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET [WAL-MART STORES INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET [WAL-MART STORES INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET [WAL-MART STORES INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-118FAMOTIDINE TABLET [DR.REDDYS LABORATORIES LIMITED]13Current NDC, Legacy NDC20240727_387088a6-8eaa-fc49-8050-a546d0f0fd32.zip

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 · 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
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
ndc (product): 55111-118

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN387088a6-8eaa-fc49-8050-a546d0f0fd3214
310273famotidine 20 MG Oral TabletPSN387088a6-8eaa-fc49-8050-a546d0f0fd3214
199047famotidine 10 MG Oral TabletSCD387088a6-8eaa-fc49-8050-a546d0f0fd3214
310273famotidine 20 MG Oral TabletSCD387088a6-8eaa-fc49-8050-a546d0f0fd3214
199047famotidine 10 MG Oral TabletPSNca039876-f7e5-3e60-da5a-a1f40637a4179
310273famotidine 20 MG Oral TabletPSNca039876-f7e5-3e60-da5a-a1f40637a4179
199047famotidine 10 MG Oral TabletSCDca039876-f7e5-3e60-da5a-a1f40637a4179
310273famotidine 20 MG Oral TabletSCDca039876-f7e5-3e60-da5a-a1f40637a4179
199047famotidine 10 MG Oral TabletPSNc5d81352-c45b-3ea1-9974-8a096bd050097
310273famotidine 20 MG Oral TabletPSNc5d81352-c45b-3ea1-9974-8a096bd050097
199047famotidine 10 MG Oral TabletSCDc5d81352-c45b-3ea1-9974-8a096bd050097
310273famotidine 20 MG Oral TabletSCDc5d81352-c45b-3ea1-9974-8a096bd050097
199047famotidine 10 MG Oral TabletPSN1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a6
310273famotidine 20 MG Oral TabletPSN1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a6
199047famotidine 10 MG Oral TabletSCD1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a6
310273famotidine 20 MG Oral TabletSCD1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a6
199047famotidine 10 MG Oral TabletPSN7fbc5e10-30c6-7f8d-1040-d48a80fe4d792
310273famotidine 20 MG Oral TabletPSN7fbc5e10-30c6-7f8d-1040-d48a80fe4d792
199047famotidine 10 MG Oral TabletSCD7fbc5e10-30c6-7f8d-1040-d48a80fe4d792
310273famotidine 20 MG Oral TabletSCD7fbc5e10-30c6-7f8d-1040-d48a80fe4d792

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
55111-118-985511101189820000 TABLET in 1 POUCH (55111-118-98)20000 tablet09-OCT-20Current