Famotidine

Product NDC
71872-7235
11-digit product format
718727235
Labeler code
71872
Product ID
71872-7235_fb339cb7-08a5-d926-e053-6394a90a6c7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Famotidine
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA075486
Marketing category
ANDA
Marketing start
2001-04-16
Substance
FAMOTIDINE
Active strength
10 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075486-001FAMOTIDINE PRESERVATIVE FREEFAMOTIDINE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075486-001AP

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-163f01610625f2…
2019-09-15 20:21 UTC2019-09A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075486-001FAMOTIDINE PRESERVATIVE FREE10MG/MLINJECTABLE / INJECTIONAPRS2001-04-16cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075486-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075486-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075486-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075486-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075486-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075486-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075486-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075486-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075486-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075486-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075486-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075486-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075486-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075486-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075486-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075486-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075486-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075486-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075486-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075486-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075486-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A075486-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075486-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075486-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075486-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A075486-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075486-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075486-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075486-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075486-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075486-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075486-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075486-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075486-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075486-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075486-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075486-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075486-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075486-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075486-001AP1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE10 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1743833Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bbeffa0a-2bc7-fea4-e053-2a95a90ac511Available 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
71872-7235-1Famotidine2 mL in 1 VIALINJECTION23
71872-7235-1Famotidine1 in 1 BAGINJECTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7235FAMOTIDINE INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC]3Current NDC, Legacy NDC, 2 package rows20230509_bbeffa0a-2bc7-fea4-e053-2a95a90ac511.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINEHikma Pharmaceuticals USA Inc.1fdf16e5-145d-4c19-a318-fc6c10794b502024-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075486
application number: ANDA075486
FamotidineFAMOTIDINEMedical Purchasing Solutions, LLCbbeffa0a-2bc7-fea4-e053-2a95a90ac5112023-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075486
application number: ANDA075486
ndc (product): 71872-7235

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743833famotidine 20 MG in 2 ML InjectionPSNbbeffa0a-2bc7-fea4-e053-2a95a90ac5113
17438332 ML famotidine 10 MG/ML InjectionSCDbbeffa0a-2bc7-fea4-e053-2a95a90ac5113
1743833famotidine 20 MG per 2 ML InjectionSYbbeffa0a-2bc7-fea4-e053-2a95a90ac5113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71872-7235-1718727235011 VIAL in 1 BAG (71872-7235-1) / 2 mL in 1 VIAL1 vial2020-12-150000-00-00NoNoCurrent