Pepcid AC

Product NDC
16837-872
11-digit product format
168370872
Labeler code
16837
Product ID
16837-872_4a227807-355e-b37d-e063-6394a90a7639
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kenvue Brands LLC
Application
NDA020325
Marketing category
NDA
Marketing start
1995-10-01
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
2027-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage16837-87216837-872-10DDiscontinued by firm2026-10-05
excluded packagepackage16837-87216837-872-31DDiscontinued by firm2026-10-05
excluded packagepackage16837-87216837-872-60DDiscontinued by firm2026-10-05
excluded packagepackage16837-87216837-872-75DDiscontinued by firm2026-10-05

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 · 35 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0516837-872-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0516837-872-31d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0516837-872-75d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2616837-872-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2616837-872-31f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2616837-872-75f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3116837-872-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3116837-872-312ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3116837-872-752ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2816837-872-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2816837-872-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2816837-872-75a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2116837-872-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2116837-872-31cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2116837-872-75cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1016837-872-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1016837-872-31cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1016837-872-75cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3116837-872-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3116837-872-31302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3116837-872-75302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2016837-872-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2016837-872-31ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2016837-872-75ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1016837-872-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1016837-872-310efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1016837-872-750efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0816837-872-31ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0816837-872-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0816837-872-75ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0316837-872-31367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0316837-872-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0316837-872-75367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0916837-872-31557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0916837-872-10557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N020325-001PEPCID ACFAMOTIDINE10MGTABLET / ORALRLD1995-04-28
N020325-002PEPCID ACFAMOTIDINE20MGTABLET / ORALRLD, RS2003-09-23

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020325-001PEPCID AC10MGTABLET / ORALRLD1995-04-2884e616aacf4f…
2026-09-14 22:38:342026-08N020325-002PEPCID AC20MGTABLET / ORALRLD, RS2003-09-2384e616aacf4f…
2026-08-18 06:07:402026-07N020325-001PEPCID AC10MGTABLET / ORALRLD1995-04-28caaa826d4ba7…
2026-08-18 06:07:402026-07N020325-002PEPCID AC20MGTABLET / ORALRLD, RS2003-09-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020325-001PEPCID AC10MGTABLET / ORALRLD1995-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020325-002PEPCID AC20MGTABLET / ORALRLD, RS2003-09-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020325-001PEPCID AC10MGTABLET / ORALRLD1995-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020325-002PEPCID AC20MGTABLET / ORALRLD, RS2003-09-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N020325-001PEPCID AC10MGTABLET / ORALRLD1995-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020325-002PEPCID AC20MGTABLET / ORALRLD, RS2003-09-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020325-001PEPCID AC10MGTABLET / ORALRLD1995-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020325-002PEPCID AC20MGTABLET / ORALRLD, RS2003-09-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020325-001PEPCID AC10MGTABLET / ORALRLD1995-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020325-002PEPCID AC20MGTABLET / ORALRLD, RS2003-09-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020325-001PEPCID AC10MGTABLET / ORALRLD1995-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020325-002PEPCID AC20MGTABLET / ORALRLD, RS2003-09-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020325-001PEPCID AC10MGTABLET / ORALRLD1995-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020325-002PEPCID AC20MGTABLET / ORALRLD, RS2003-09-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020325-001PEPCID AC10MGTABLET / ORALRLD1995-04-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020325-002PEPCID AC20MGTABLET / ORALRLD, RS2003-09-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020325-001PEPCID AC10MGTABLET / ORALRLD1995-04-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020325-002PEPCID AC20MGTABLET / ORALRLD, RS2003-09-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020325-001PEPCID AC10MGTABLET / ORALRLD1995-04-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N020325-002PEPCID AC20MGTABLET / ORALRLD, RS2003-09-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020325-001PEPCID AC10MGTABLET / ORALRLD1995-04-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020325-002PEPCID AC20MGTABLET / ORALRLD, RS2003-09-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020325-001PEPCID AC10MGTABLET / ORALRLD1995-04-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020325-002PEPCID AC20MGTABLET / ORALRLD, RS2003-09-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020325-001PEPCID AC10MGTABLET / ORALRLD1995-04-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020325-002PEPCID AC20MGTABLET / ORALRLD, RS2003-09-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020325-001PEPCID AC10MGTABLET / ORALRLD1995-04-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020325-002PEPCID AC20MGTABLET / ORALRLD, RS2003-09-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020325-001PEPCID AC10MGTABLET / ORALRLD1995-04-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020325-002PEPCID AC20MGTABLET / ORALRLD, RS2003-09-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020325-001PEPCID AC10MGTABLET / ORALRLD1995-04-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020325-002PEPCID AC20MGTABLET / ORALRLD, RS2003-09-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020325-001PEPCID AC10MGTABLET / ORALRLD1995-04-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020325-002PEPCID AC20MGTABLET / ORALRLD, RS2003-09-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020325-001PEPCID AC10MGTABLET / ORALRLD1995-04-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020325-002PEPCID AC20MGTABLET / ORALRLD, RS2003-09-2374a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Pepcid AC
Brand name suffix
Original Strength
Listing expiration
2027-12-31

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
212072Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
54f4086f-e443-4e7e-8c7e-94e152e1c256Available 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
16837-872-10Pepcid ACOriginal Strength10 in 1 BLISTER PACKTABLET, FILM COATED1020
16837-872-10Pepcid ACOriginal Strength1 in 1 CARTONTABLET, FILM COATED120
16837-872-20Pepcid ACOriginal Strength3 in 1 CARTONTABLET, FILM COATED320
16837-872-20Pepcid ACOriginal Strength10 in 1 BLISTER PACKTABLET, FILM COATED1020
16837-872-22Pepcid ACOriginal Strength1 in 1 CARTONTABLET, FILM COATED120
16837-872-22Pepcid ACOriginal Strength90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9020
16837-872-30Pepcid ACOriginal Strength3 in 1 CARTONTABLET, FILM COATED320
16837-872-30Pepcid ACOriginal Strength10 in 1 BLISTER PACKTABLET, FILM COATED1020
16837-872-31Pepcid ACOriginal Strength4 in 1 CARTONTABLET, FILM COATED420
16837-872-31Pepcid ACOriginal Strength10 in 1 BLISTER PACKTABLET, FILM COATED1020
16837-872-60Pepcid ACOriginal Strength1 in 1 CARTONTABLET, FILM COATED120
16837-872-60Pepcid ACOriginal Strength60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6020
16837-872-75Pepcid ACOriginal Strength1 in 1 CARTONTABLET, FILM COATED120
16837-872-75Pepcid ACOriginal Strength75 in 1 BOTTLE, PLASTICTABLET, FILM COATED7520
16837-872-90Pepcid ACOriginal Strength1 in 1 CARTONTABLET, FILM COATED120
16837-872-90Pepcid ACOriginal Strength90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16837-872-20EA - Each16837-872ed3bdbd8-a9ff-41b4-97d5-1a3c830db28a12020-06-05
16837-872-22EA - Each16837-872e277def6-18e6-4165-9944-4015a4a0dd0512021-05-05
16837-872-30EA - Each16837-87236ded51f-29fb-4eda-a14b-fa89ccec2f0412018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FamotidineACTIVE INGREDIENT5QZO15J2Z8PEPCID AC ORIGINAL STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]5
FamotidineACTIVE MOIETY5QZO15J2Z8PEPCID AC ORIGINAL STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]5
carnauba waxINACTIVE INGREDIENTR12CBM0EIZPEPCID AC ORIGINAL STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]5
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UPEPCID AC ORIGINAL STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]5
ferric oxide redINACTIVE INGREDIENT1K09F3G675PEPCID AC ORIGINAL STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]5
HYDROXYPROPYL CELLULOSE (TYPE L)INACTIVE INGREDIENTUKE75GEA7FPEPCID AC ORIGINAL STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]5
hypromellosesINACTIVE INGREDIENT3NXW29V3WOPEPCID AC ORIGINAL STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]5
magnesium stearateINACTIVE INGREDIENT70097M6I30PEPCID AC ORIGINAL STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]5
talcINACTIVE INGREDIENT7SEV7J4R1UPEPCID AC ORIGINAL STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]5
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPEPCID AC ORIGINAL STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16837-872PEPCID AC ORIGINAL STRENGTH (FAMOTIDINE) TABLET, FILM COATED [KENVUE BRANDS LLC]19Current NDC, Legacy NDC, 16 package rows20241114_54f4086f-e443-4e7e-8c7e-94e152e1c256.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pepcid AC Original StrengthFAMOTIDINEKenvue Brands LLC54f4086f-e443-4e7e-8c7e-94e152e1c2562026-02-06WarningsExact identifier
application applno (NDA): 020325
application number: NDA020325
ndc (product): 16837-872
PEPCID AC Maximum StrengthFAMOTIDINEKenvue Brands LLC2854047f-c5c4-43c3-8ef2-5c0a84a307f22024-11-11WarningsExact identifier
application applno (NDA): 020325
application number: NDA020325
Maximum Strength PEPCID AC Icy Cool MintFAMOTIDINEKenvue Brands LLC0f343092-4fc7-1fff-e063-6294a90aba6e2024-11-11WarningsExact identifier
application applno (NDA): 020325
application number: NDA020325
Pepcid ACFAMOTIDINELil' Drug Store Products, Inc.14406cd8-468b-403d-9be2-43decd3042142024-01-09WarningsExact identifier
application applno (NDA): 020325
application number: NDA020325

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN54f4086f-e443-4e7e-8c7e-94e152e1c25620
212072Pepcid AC 10 MG Oral TabletPSN54f4086f-e443-4e7e-8c7e-94e152e1c25620
212072famotidine 10 MG Oral Tablet [Pepcid]SBD54f4086f-e443-4e7e-8c7e-94e152e1c25620
199047famotidine 10 MG Oral TabletSCD54f4086f-e443-4e7e-8c7e-94e152e1c25620
212072Pepcid 10 MG Oral TabletSY54f4086f-e443-4e7e-8c7e-94e152e1c25620
212072Pepcid AC Original 10 MG Oral TabletSY54f4086f-e443-4e7e-8c7e-94e152e1c25620

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16837-872-10168370872101 BLISTER PACK in 1 CARTON (16837-872-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2011-01-210000-00-00NoNoCurrent
16837-872-20168370872203 BLISTER PACK in 1 CARTON (16837-872-20) / 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2011-01-210000-00-00NoNoCurrent
16837-872-22168370872221 BOTTLE, PLASTIC in 1 CARTON (16837-872-22) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2011-01-210000-00-00NoNoCurrent
16837-872-30168370872303 BLISTER PACK in 1 CARTON (16837-872-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack1995-10-010000-00-00NoNoCurrent
16837-872-31168370872314 BLISTER PACK in 1 CARTON (16837-872-31) > 10 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack1995-10-010000-00-00NoNoCurrent
16837-872-60168370872601 BOTTLE, PLASTIC in 1 CARTON (16837-872-60) > 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1995-10-010000-00-00NoNoCurrent
16837-872-75168370872751 BOTTLE, PLASTIC in 1 CARTON (16837-872-75) > 75 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2021-03-150000-00-00NoNoCurrent
16837-872-90168370872901 BOTTLE, PLASTIC in 1 CARTON (16837-872-90) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1995-10-010000-00-00NoNoCurrent