Famotidine

Product NDC
65862-860
Requested package NDC
65862-860-49
11-digit product format
658620860
Labeler code
65862
Product ID
65862-860_e0c726f6-8257-4dba-b2f9-d78d28097bd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA206530
Marketing category
ANDA
Marketing start
2015-12-22
Substance
FAMOTIDINE
Active strength
40 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 packagepackage65862-86065862-860-49UNFINISHEDActive or certified unfinished drug listing2026-08-03

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 · 21 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…
2020-06-10 20:45 UTC · source 2020-06-104bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-305b2001dcd8f5…54b53d4dc9e4…

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
A206530-001FAMOTIDINEFAMOTIDINE20MGTABLET / ORALAB2015-12-22
A206530-002FAMOTIDINEFAMOTIDINE40MGTABLET / ORALABRS2015-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A206530-001AB
A206530-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206530-001FAMOTIDINE20MGTABLET / ORALAB2015-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206530-002FAMOTIDINE40MGTABLET / ORALABRS2015-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206530-001FAMOTIDINE20MGTABLET / ORALAB2015-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206530-002FAMOTIDINE40MGTABLET / ORALABRS2015-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A206530-001FAMOTIDINE20MGTABLET / ORALAB2015-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206530-002FAMOTIDINE40MGTABLET / ORALABRS2015-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206530-001FAMOTIDINE20MGTABLET / ORALAB2015-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206530-002FAMOTIDINE40MGTABLET / ORALABRS2015-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206530-001FAMOTIDINE20MGTABLET / ORALAB2015-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206530-002FAMOTIDINE40MGTABLET / ORALABRS2015-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206530-001FAMOTIDINE20MGTABLET / ORALAB2015-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206530-002FAMOTIDINE40MGTABLET / ORALABRS2015-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206530-001FAMOTIDINE20MGTABLET / ORALAB2015-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206530-002FAMOTIDINE40MGTABLET / ORALABRS2015-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206530-001FAMOTIDINE20MGTABLET / ORALAB2015-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206530-002FAMOTIDINE40MGTABLET / ORALABRS2015-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206530-001FAMOTIDINE20MGTABLET / ORALAB2015-12-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206530-002FAMOTIDINE40MGTABLET / ORALABRS2015-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206530-001FAMOTIDINE20MGTABLET / ORALAB2015-12-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A206530-002FAMOTIDINE40MGTABLET / ORALABRS2015-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206530-001FAMOTIDINE20MGTABLET / ORALAB2015-12-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206530-002FAMOTIDINE40MGTABLET / ORALABRS2015-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206530-001FAMOTIDINE20MGTABLET / ORALAB2015-12-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206530-002FAMOTIDINE40MGTABLET / ORALABRS2015-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206530-001FAMOTIDINE20MGTABLET / ORALAB2015-12-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206530-002FAMOTIDINE40MGTABLET / ORALABRS2015-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206530-001FAMOTIDINE20MGTABLET / ORALAB2015-12-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206530-002FAMOTIDINE40MGTABLET / ORALABRS2015-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206530-001FAMOTIDINE20MGTABLET / ORALAB2015-12-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206530-002FAMOTIDINE40MGTABLET / ORALABRS2015-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206530-001FAMOTIDINE20MGTABLET / ORALAB2015-12-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206530-002FAMOTIDINE40MGTABLET / ORALABRS2015-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206530-001FAMOTIDINE20MGTABLET / ORALAB2015-12-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206530-002FAMOTIDINE40MGTABLET / ORALABRS2015-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206530-001FAMOTIDINE20MGTABLET / ORALAB2015-12-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206530-002FAMOTIDINE40MGTABLET / ORALAB2015-12-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206530-001FAMOTIDINE20MGTABLET / ORALAB2015-12-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206530-002FAMOTIDINE40MGTABLET / ORALABRS2015-12-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206530-001FAMOTIDINE20MGTABLET / ORALAB2015-12-22782e0a99824c…
2021-12-28 21:50 UTC2021-12A206530-002FAMOTIDINE40MGTABLET / ORALABRS2015-12-22782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206530-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206530-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206530-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206530-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206530-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206530-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206530-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206530-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206530-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206530-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206530-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206530-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206530-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206530-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206530-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206530-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206530-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206530-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206530-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206530-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206530-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206530-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206530-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206530-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206530-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206530-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206530-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206530-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206530-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206530-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206530-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206530-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206530-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206530-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206530-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206530-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206530-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206530-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206530-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A206530-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE40 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
284245Internal 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
b0798337-1a73-415e-8416-613984ce5c65Available 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
65862-860-01Famotidine100 in 1 BOTTLETABLET, FILM COATED10010
65862-860-05Famotidine500 in 1 BOTTLETABLET, FILM COATED50010
65862-860-10Famotidine10 in 1 BLISTER PACKTABLET, FILM COATED1010
65862-860-30Famotidine30 in 1 BOTTLETABLET, FILM COATED3010
65862-860-78Famotidine10 in 1 CARTONTABLET, FILM COATED1010
65862-860-99Famotidine1000 in 1 BOTTLETABLET, FILM COATED100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-860-01EA - Each65862-860a1fe089f-a6f4-45ff-8cc4-42830de4326912016-05-16
65862-860-99EA - Each65862-860b62bffaf-541c-4ca0-803f-368096bd435712017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-860FAMOTIDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]10Current NDC, Legacy NDC, 6 package rows20250308_b0798337-1a73-415e-8416-613984ce5c65.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
FamotidineFAMOTIDINEUnit Dose Solutions, Inc.54d93bf1-8f9a-981b-e063-6394a90a0fde2026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206530
application number: ANDA206530
FamotidineFAMOTIDINEBryant Ranch Prepack11ce2a78-76ce-44df-afe3-57493498e5962025-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206530
application number: ANDA206530
FamotidineFAMOTIDINEAurobindo Pharma Limitedb0798337-1a73-415e-8416-613984ce5c652025-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206530
application number: ANDA206530
ndc (product): 65862-860
FamotidineFAMOTIDINEAmerican Health Packaging3a583080-6771-4246-a221-2491e9e5d8af2024-09-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206530
application number: ANDA206530
FamotidineFAMOTIDINEProficient Rx LP4adb4864-04ac-4cb1-96c2-6196a30ac6402024-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206530
application number: ANDA206530
FamotidineFAMOTIDINEA-S Medication Solutionsd8cfa644-7cad-41b9-82a0-242a783fcbc82023-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206530
application number: ANDA206530
FamotidineFAMOTIDINEProficient Rx LPf32d0929-de22-4bec-9e24-bb549cf2679f2022-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206530
application number: ANDA206530
FamotidineFAMOTIDINEBluePoint Laboratories8c7ca3cc-ff90-42a7-9218-554cf15348a32021-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206530
application number: ANDA206530

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNb0798337-1a73-415e-8416-613984ce5c6510
284245famotidine 40 MG Oral TabletPSNb0798337-1a73-415e-8416-613984ce5c6510
310273famotidine 20 MG Oral TabletSCDb0798337-1a73-415e-8416-613984ce5c6510
284245famotidine 40 MG Oral TabletSCDb0798337-1a73-415e-8416-613984ce5c6510
284245famotidine 40 MG Oral TabletPSNba35f425-9321-4fd8-91d4-053a1edb3a055
284245famotidine 40 MG Oral TabletSCDba35f425-9321-4fd8-91d4-053a1edb3a055
284245famotidine 40 MG Oral TabletPSNf32d0929-de22-4bec-9e24-bb549cf2679f2
284245famotidine 40 MG Oral TabletSCDf32d0929-de22-4bec-9e24-bb549cf2679f2
284245famotidine 40 MG Oral TabletPSNd8cfa644-7cad-41b9-82a0-242a783fcbc81
284245famotidine 40 MG Oral TabletSCDd8cfa644-7cad-41b9-82a0-242a783fcbc81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startStatus
65862-860-49658620860494000 TABLET, FILM COATED in 1 BAG (65862-860-49)22-DEC-15Current