Famotidine

Product NDC
61442-121
11-digit product format
614420121
Labeler code
61442
Product ID
61442-121_206161c2-b8ce-04c1-e063-6294a90ac404
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Carlsbad Technology, Inc
Application
ANDA075805
Marketing category
ANDA
Marketing start
2001-04-16
Substance
FAMOTIDINE
Active strength
20 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
A075805-001FAMOTIDINEFAMOTIDINE20MGTABLET / ORALAB2001-04-16
A075805-002FAMOTIDINEFAMOTIDINE40MGTABLET / ORALAB2001-04-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075805-001AB
A075805-002AB

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 UTC2026-02A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075805-001FAMOTIDINE20MGTABLET / ORALAB2001-04-16782e0a99824c…
2021-12-28 21:50 UTC2021-12A075805-002FAMOTIDINE40MGTABLET / ORALAB2001-04-16782e0a99824c…

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 UTC2026-02A075805-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075805-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075805-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075805-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075805-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075805-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075805-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075805-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075805-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075805-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075805-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075805-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075805-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075805-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075805-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075805-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075805-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075805-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075805-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075805-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075805-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075805-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075805-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075805-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075805-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075805-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075805-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075805-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075805-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075805-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075805-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075805-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075805-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075805-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075805-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075805-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075805-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075805-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075805-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075805-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE20 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
a8b5c855-053d-4295-8f57-1a96a6ccaa92Available 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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61442-121-01Famotidine24 in 1 BOXTABLET247
61442-121-01Famotidine100 in 1 BOTTLETABLET1007
61442-121-05Famotidine500 in 1 BOTTLETABLET5007
61442-121-05Famotidine24 in 1 BOXTABLET247
61442-121-10Famotidine1000 in 1 BOTTLETABLET10007
61442-121-10Famotidine12 in 1 BOXTABLET127
61442-121-30Famotidine30 in 1 BOTTLETABLET307
61442-121-30Famotidine24 in 1 BOXTABLET247

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61442-121-01EA - Each61442-1215d70f37a-afff-4376-80c3-10754049cf6612012-07-24
61442-121-10EA - Each61442-121dd86737d-9440-4632-8ac1-804d05db10d312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FamotidineACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3438
FamotidineACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3438
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3438
magnesium stearateINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3438
polydextroseINACTIVE INGREDIENTVH2XOU12IEFAMOTIDINE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3438
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2FAMOTIDINE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3438
starch, cornINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3438
talcINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3438
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3438
triacetinINACTIVE INGREDIENTXHX3C3X673FAMOTIDINE TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3438
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET [BRYANT RANCH PREPACK]3
FamotidineACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET [CARLSBAD TECHNOLOGY, INC]3
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET [BRYANT RANCH PREPACK]3
FamotidineACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET [CARLSBAD TECHNOLOGY, INC]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET [CARLSBAD TECHNOLOGY, INC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET [BRYANT RANCH PREPACK]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET [BRYANT RANCH PREPACK]3
magnesium stearateINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET [CARLSBAD TECHNOLOGY, INC]3
polydextroseINACTIVE INGREDIENTVH2XOU12IEFAMOTIDINE TABLET [CARLSBAD TECHNOLOGY, INC]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEFAMOTIDINE TABLET [BRYANT RANCH PREPACK]3
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2FAMOTIDINE TABLET [CARLSBAD TECHNOLOGY, INC]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FAMOTIDINE TABLET [BRYANT RANCH PREPACK]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET [BRYANT RANCH PREPACK]3
starch, cornINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET [CARLSBAD TECHNOLOGY, INC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET [BRYANT RANCH PREPACK]3
talcINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET [CARLSBAD TECHNOLOGY, INC]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET [CARLSBAD TECHNOLOGY, INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET [BRYANT RANCH PREPACK]3
TRIACETININACTIVE INGREDIENTXHX3C3X673FAMOTIDINE TABLET [BRYANT RANCH PREPACK]3
triacetinINACTIVE INGREDIENTXHX3C3X673FAMOTIDINE TABLET [CARLSBAD TECHNOLOGY, INC]3
FamotidineACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET [UNIT DOSE SERVICES]2
FamotidineACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET [UNIT DOSE SERVICES]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEFAMOTIDINE TABLET [UNIT DOSE SERVICES]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FAMOTIDINE TABLET [UNIT DOSE SERVICES]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET [UNIT DOSE SERVICES]2
TALCINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET [UNIT DOSE SERVICES]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET [UNIT DOSE SERVICES]2
TRIACETININACTIVE INGREDIENTXHX3C3X673FAMOTIDINE TABLET [UNIT DOSE SERVICES]2
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET [BLENHEIM PHARMACAL, INC.]1
FamotidineACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET [DIRECT RX]1
FamotidineACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
FamotidineACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET [DIRECT RX]1
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET [BLENHEIM PHARMACAL, INC.]1
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
FamotidineACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
FamotidineACTIVE MOIETY5QZO15J2Z8FAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET [BLENHEIM PHARMACAL, INC.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
magnesium stearateINACTIVE INGREDIENT70097M6I30FAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
magnesium stearateINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET [DIRECT RX]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEFAMOTIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
polydextroseINACTIVE INGREDIENTVH2XOU12IEFAMOTIDINE TABLET [DIRECT RX]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEFAMOTIDINE TABLET [BLENHEIM PHARMACAL, INC.]1
polydextroseINACTIVE INGREDIENTVH2XOU12IEFAMOTIDINE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
polydextroseINACTIVE INGREDIENTVH2XOU12IEFAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FAMOTIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FAMOTIDINE TABLET [BLENHEIM PHARMACAL, INC.]1
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2FAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2FAMOTIDINE TABLET [DIRECT RX]1
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2FAMOTIDINE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET [BLENHEIM PHARMACAL, INC.]1
starch, cornINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
starch, cornINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET [DIRECT RX]1
starch, cornINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
talcINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
talcINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET [DIRECT RX]1
talcINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
TALCINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET [BLENHEIM PHARMACAL, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673FAMOTIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
triacetinINACTIVE INGREDIENTXHX3C3X673FAMOTIDINE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
triacetinINACTIVE INGREDIENTXHX3C3X673FAMOTIDINE TABLET [DIRECT RX]1
TRIACETININACTIVE INGREDIENTXHX3C3X673FAMOTIDINE TABLET [BLENHEIM PHARMACAL, INC.]1
triacetinINACTIVE INGREDIENTXHX3C3X673FAMOTIDINE (FAMOTIDINE) TABLET [AVPAK]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61442-121FAMOTIDINE TABLET [CARLSBAD TECHNOLOGY, INC]7Current NDC, Legacy NDC, 8 package rows20240828_a8b5c855-053d-4295-8f57-1a96a6ccaa92.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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINEA-S Medication Solutionsd0558e97-3bc3-4a1e-9248-1959b03440232026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINENorthwind Health Company, LLCab1cdbbf-d838-020c-e053-2995a90a0f652026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEAvPAK85c7d20d-3dec-b918-4c1d-8ca1db214e482025-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.66f0bf15-ff35-426a-b40c-0d0da79d08612025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.09ef39a4-c6b3-4395-8211-3f551dc448302025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FAMOTIDINEFAMOTIDINEdirect rxc3de241e-6217-d6e0-e053-2a95a90a35c52025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEGolden State Medical Supply, Inc.f67bcbc7-952c-61c0-e053-2a95a90a6fa62024-09-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEBryant Ranch Prepack67a6e7f3-04d6-426c-b952-7677a84ace4d2024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEBryant Ranch Prepack3031c7d1-5a4e-42b3-a3ca-9ac2ea2f76fb2024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEBryant Ranch Prepack92a75aa6-3c63-4c98-be8e-dcd03affc10b2024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEBryant Ranch Prepack81f24752-3474-3013-0013-5570c8e7baf72024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEBryant Ranch Prepack82930f64-4556-491f-96cc-270be9e3589a2024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINECarlsbad Technology, Inca8b5c855-053d-4295-8f57-1a96a6ccaa922024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
ndc (product): 61442-121
FamotidineFAMOTIDINENuCare Pharmaceuticals,Inc.b556d1a8-4155-50cf-e053-2995a90a9b142024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINENuCare Pharmaceuticals,Inc.60cd0973-f74e-2b70-e053-2a91aa0a43612024-06-06Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
PepcidFAMOTIDINEBausch Health US LLCa06502d9-7903-4f37-833e-e5763d502def2024-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEA-S Medication Solutionsae3646c7-76fc-473d-b20b-67d3c6ac0b752023-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEProficient Rx LPc84b0ba3-1ba8-4da9-b5b8-186e01cda9992022-07-01Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEAphena Pharma Solutions - Tennessee, LLC46c6d243-eefc-40ca-8bd4-4c89456f635f2021-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805
FamotidineFAMOTIDINEProficient Rx LP1e2003d4-09a3-4cc8-af3d-93d29b9123c02020-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075805
application number: ANDA075805

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNb85f7b42-3012-4cbb-a805-74ea665636e61111777777
310273famotidine 20 MG Oral TabletSCDb85f7b42-3012-4cbb-a805-74ea665636e61111777777
310273famotidine 20 MG Oral TabletPSNae3646c7-76fc-473d-b20b-67d3c6ac0b7522
284245famotidine 40 MG Oral TabletPSNae3646c7-76fc-473d-b20b-67d3c6ac0b7522
310273famotidine 20 MG Oral TabletSCDae3646c7-76fc-473d-b20b-67d3c6ac0b7522
284245famotidine 40 MG Oral TabletSCDae3646c7-76fc-473d-b20b-67d3c6ac0b7522
310273famotidine 20 MG Oral TabletPSN66f0bf15-ff35-426a-b40c-0d0da79d086120
310273famotidine 20 MG Oral TabletSCD66f0bf15-ff35-426a-b40c-0d0da79d086120
310273famotidine 20 MG Oral TabletPSN4e0291a4-1643-4660-e054-00144ff8d46c10
310273famotidine 20 MG Oral TabletPSN81f24752-3474-3013-0013-5570c8e7baf710
284245famotidine 40 MG Oral TabletPSN81f24752-3474-3013-0013-5570c8e7baf710
310273famotidine 20 MG Oral TabletSCD81f24752-3474-3013-0013-5570c8e7baf710
310273famotidine 20 MG Oral TabletSCD4e0291a4-1643-4660-e054-00144ff8d46c10
284245famotidine 40 MG Oral TabletSCD81f24752-3474-3013-0013-5570c8e7baf710
310273famotidine 20 MG Oral TabletPSN8fa16dc6-0ef1-2f48-e053-2a95a90a83ed8
310273famotidine 20 MG Oral TabletSCD8fa16dc6-0ef1-2f48-e053-2a95a90a83ed8
310273famotidine 20 MG Oral TabletPSN85c7d20d-3dec-b918-4c1d-8ca1db214e487
310273famotidine 20 MG Oral TabletPSNa8b5c855-053d-4295-8f57-1a96a6ccaa927
284245famotidine 40 MG Oral TabletPSN85c7d20d-3dec-b918-4c1d-8ca1db214e487
284245famotidine 40 MG Oral TabletPSNa8b5c855-053d-4295-8f57-1a96a6ccaa927
310273famotidine 20 MG Oral TabletSCD85c7d20d-3dec-b918-4c1d-8ca1db214e487
310273famotidine 20 MG Oral TabletSCDa8b5c855-053d-4295-8f57-1a96a6ccaa927
284245famotidine 40 MG Oral TabletSCD85c7d20d-3dec-b918-4c1d-8ca1db214e487
284245famotidine 40 MG Oral TabletSCDa8b5c855-053d-4295-8f57-1a96a6ccaa927
310273famotidine 20 MG Oral TabletPSN3031c7d1-5a4e-42b3-a3ca-9ac2ea2f76fb6
310273famotidine 20 MG Oral TabletSCD3031c7d1-5a4e-42b3-a3ca-9ac2ea2f76fb6
310273famotidine 20 MG Oral TabletPSNab1cdbbf-d838-020c-e053-2995a90a0f655
310273famotidine 20 MG Oral TabletSCDab1cdbbf-d838-020c-e053-2995a90a0f655
310273famotidine 20 MG Oral TabletPSNb556d1a8-4155-50cf-e053-2995a90a9b144
310273famotidine 20 MG Oral TabletPSNf55c8069-bfc1-4e37-b359-d3d1b10804ae4
310273famotidine 20 MG Oral TabletPSNc84b0ba3-1ba8-4da9-b5b8-186e01cda9994
310273famotidine 20 MG Oral TabletPSNd7650e7f-f95b-4cc1-9e96-28c676112c1b4
310273famotidine 20 MG Oral TabletPSN18959b62-4c58-40cd-837f-ff263e1ce8e14
310273famotidine 20 MG Oral TabletSCDd7650e7f-f95b-4cc1-9e96-28c676112c1b4
310273famotidine 20 MG Oral TabletSCDc84b0ba3-1ba8-4da9-b5b8-186e01cda9994
310273famotidine 20 MG Oral TabletSCDf55c8069-bfc1-4e37-b359-d3d1b10804ae4
310273famotidine 20 MG Oral TabletSCDb556d1a8-4155-50cf-e053-2995a90a9b144
310273famotidine 20 MG Oral TabletSCD18959b62-4c58-40cd-837f-ff263e1ce8e14
310273famotidine 20 MG Oral TabletPSNf67bcbc7-952c-61c0-e053-2a95a90a6fa63
284245famotidine 40 MG Oral TabletPSNf67bcbc7-952c-61c0-e053-2a95a90a6fa63
310273famotidine 20 MG Oral TabletSCDf67bcbc7-952c-61c0-e053-2a95a90a6fa63
284245famotidine 40 MG Oral TabletSCDf67bcbc7-952c-61c0-e053-2a95a90a6fa63
310273famotidine 20 MG Oral TabletPSNe98b465b-62a0-4aef-86e8-54bf5b2e054c1
310273famotidine 20 MG Oral TabletPSNbfc9e530-3433-4fed-a542-0e64123cddfb1
310273famotidine 20 MG Oral TabletPSN1221646b-ea71-1ce9-e054-00144ff8d46c1
310273famotidine 20 MG Oral TabletSCDe98b465b-62a0-4aef-86e8-54bf5b2e054c1
310273famotidine 20 MG Oral TabletSCDbfc9e530-3433-4fed-a542-0e64123cddfb1
310273famotidine 20 MG Oral TabletSCD1221646b-ea71-1ce9-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61442-121-016144201210124 BOTTLE in 1 BOX (61442-121-01) / 100 TABLET in 1 BOTTLE24 bottle2001-04-160000-00-00NoNoCurrent
61442-121-056144201210524 BOTTLE in 1 BOX (61442-121-05) / 500 TABLET in 1 BOTTLE24 bottle2001-04-160000-00-00NoNoCurrent
61442-121-106144201211012 BOTTLE in 1 BOX (61442-121-10) / 1000 TABLET in 1 BOTTLE12 bottle2001-04-160000-00-00NoNoCurrent
61442-121-306144201213024 BOTTLE in 1 BOX (61442-121-30) / 30 TABLET in 1 BOTTLE24 bottle2001-04-160000-00-00NoNoCurrent