PEPCID AC

Product NDC: 16837-855
Requested package NDC: 16837-855-49
11-digit product format: 168370855
Labeler code: 16837
Product ID: 16837-855_21af0de6-18c5-b8e8-e063-6394a90af51f
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: 2003-09-01
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

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	16837-855	16837-855-49	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020325-001	PEPCID AC	FAMOTIDINE	10MG	TABLET / ORAL		RLD	1995-04-28
N020325-002	PEPCID AC	FAMOTIDINE	20MG	TABLET / ORAL		RLD, RS	2003-09-23

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: PEPCID AC
Brand name suffix: Maximum Strength
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FAMOTIDINE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5QZO15J2Z8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
104094	Internal RxNorm lookup
310273	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
2854047f-c5c4-43c3-8ef2-5c0a84a307f2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcae	Product name	7	20260317
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
cf645750-2e70-f6e1-c05a-a52847def5dd	Product name	9	20250312
4fdc761c-585e-054b-8ebe-86130a26e4c1	Product name	2	20221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
16837-855-02	PEPCID ® AC Maximum Strength
16837-855-05	PEPCID ® AC Maximum Strength
16837-855-09	PEPCID ® AC Maximum Strength
16837-855-12	PEPCID ® AC Maximum Strength
16837-855-13	PEPCID ® AC Maximum Strength
16837-855-14	PEPCID ® AC Maximum Strength
16837-855-15	PEPCID ® AC Maximum Strength
16837-855-16	PEPCID ® AC Maximum Strength
16837-855-17	PEPCID ® AC Maximum Strength
16837-855-18	PEPCID ® AC Maximum Strength
16837-855-19	PEPCID ® AC Maximum Strength
16837-855-20	PEPCID ® AC Maximum Strength
16837-855-24	PEPCID ® AC Maximum Strength
16837-855-25	PEPCID ® AC Maximum Strength
16837-855-40	PEPCID ® AC Maximum Strength
16837-855-49	PEPCID ® AC Maximum Strength
16837-855-50	PEPCID ® AC Maximum Strength
16837-855-51	PEPCID ® AC Maximum Strength
16837-855-52	PEPCID ® AC Maximum Strength
16837-855-65	PEPCID ® AC Maximum Strength
16837-855-67	PEPCID ® AC Maximum Strength
16837-855-70	PEPCID ® AC Maximum Strength
16837-855-75	PEPCID ® AC Maximum Strength
16837-855-80	PEPCID ® AC Maximum Strength
16837-855-85	PEPCID ® AC Maximum Strength
16837-855-90	PEPCID ® AC Maximum Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16837-855-02	PEPCID ACMaximum Strength	2 in 1 CARTON	TABLET, FILM COATED	2	23
16837-855-02	PEPCID ACMaximum Strength	1 in 1 POUCH	TABLET, FILM COATED	1	23
16837-855-05	PEPCID ACMaximum Strength	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	23
16837-855-05	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-09	PEPCID ACMaximum Strength	1 in 1 PACKAGE	TABLET, FILM COATED	1	23
16837-855-09	PEPCID ACMaximum Strength	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	23
16837-855-12	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-12	PEPCID ACMaximum Strength	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	23
16837-855-13	PEPCID ACMaximum Strength	1 in 1 POUCH	TABLET, FILM COATED	1	23
16837-855-14	PEPCID ACMaximum Strength	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	23
16837-855-14	PEPCID ACMaximum Strength	5 in 1 CARTON	TABLET, FILM COATED	5	23
16837-855-15	PEPCID ACMaximum Strength	35 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	35	23
16837-855-15	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-16	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-16	PEPCID ACMaximum Strength	50 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	50	23
16837-855-17	PEPCID ACMaximum Strength	65 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	65	23
16837-855-17	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-18	PEPCID ACMaximum Strength	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	23
16837-855-18	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-19	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-19	PEPCID ACMaximum Strength	8 in 1 BLISTER PACK	TABLET, FILM COATED	8	23
16837-855-20	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-20	PEPCID ACMaximum Strength	2 in 1 PACKAGE	TABLET, FILM COATED	2	23
16837-855-24	PEPCID ACMaximum Strength	1 in 1 POUCH	TABLET, FILM COATED	1	23
16837-855-24	PEPCID ACMaximum Strength	2500 in 1 CARTON	TABLET, FILM COATED	2500	23
16837-855-25	PEPCID ACMaximum Strength	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	23
16837-855-25	PEPCID ACMaximum Strength	5 in 1 CARTON	TABLET, FILM COATED	5	23
16837-855-40	PEPCID ACMaximum Strength	8 in 1 BLISTER PACK	TABLET, FILM COATED	8	23
16837-855-40	PEPCID ACMaximum Strength	5 in 1 CARTON	TABLET, FILM COATED	5	23
16837-855-49	PEPCID ACMaximum Strength	50 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	50	23
16837-855-49	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-50	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-50	PEPCID ACMaximum Strength	50 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	50	23
16837-855-51	PEPCID ACMaximum Strength	12 in 1 CARTON	TABLET, FILM COATED	12	23
16837-855-51	PEPCID ACMaximum Strength	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	23
16837-855-52	PEPCID ACMaximum Strength	50 in 1 TRAY	TABLET, FILM COATED	50	23
16837-855-52	PEPCID ACMaximum Strength	1 in 1 POUCH	TABLET, FILM COATED	1	23
16837-855-65	PEPCID ACMaximum Strength	65 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	65	23
16837-855-65	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-67	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-67	PEPCID ACMaximum Strength	65 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	65	23
16837-855-70	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-70	PEPCID ACMaximum Strength	70 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	70	23
16837-855-75	PEPCID ACMaximum Strength	75 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	75	23
16837-855-75	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-80	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-80	PEPCID ACMaximum Strength	80 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	80	23
16837-855-85	PEPCID ACMaximum Strength	85 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	85	23
16837-855-85	PEPCID ACMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	23
16837-855-90	PEPCID ACMaximum Strength	125 in 1 PACKAGE, COMBINATION	TABLET, FILM COATED	125	23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16837-855-14	EA - Each	16837-855	f235e0f8-899b-4d70-b432-965d7c89b25c	1	2020-05-08
16837-855-20	EA - Each	16837-855	4e0b3b00-4286-40fa-a8aa-8b200f0a17e7	1	2018-11-06
16837-855-25	EA - Each	16837-855	89ae8e30-8f54-4a60-b156-360669f64745	1	2018-03-08
16837-855-50	EA - Each	16837-855	16402839-23a8-4222-905a-c7d62af2b461	1	2018-03-08
16837-855-75	EA - Each	16837-855	662f0682-7aa8-4682-8bad-99d851f4bb76	1	2021-08-05
16837-855-90	EA - Each	16837-855	a5a3e34d-e891-46b1-895f-5175a172f94e	1	2021-03-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Famotidine	ACTIVE INGREDIENT	5QZO15J2Z8	PEPCID AC MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]	6
Famotidine	ACTIVE MOIETY	5QZO15J2Z8	PEPCID AC MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]	6
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	PEPCID AC MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]	6
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	PEPCID AC MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]	6
hydroxypropyl cellulose (type L)	INACTIVE INGREDIENT	UKE75GEA7F	PEPCID AC MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]	6
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	PEPCID AC MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]	6
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PEPCID AC MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]	6
talc	INACTIVE INGREDIENT	7SEV7J4R1U	PEPCID AC MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]	6
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	PEPCID AC MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [MCNEIL CONSUMER PHARMACEUTICALS CO.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16837-855	PEPCID AC MAXIMUM STRENGTH (FAMOTIDINE) TABLET, FILM COATED [KENVUE BRANDS LLC]	23	Current NDC, Legacy NDC, 50 package rows	20241114_2854047f-c5c4-43c3-8ef2-5c0a84a307f2.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pepcid AC Original Strength	FAMOTIDINE	Kenvue Brands LLC	54f4086f-e443-4e7e-8c7e-94e152e1c256	2026-02-06	Warnings	Exact identifier application applno (NDA): 020325 application number: NDA020325
PEPCID AC Maximum Strength	FAMOTIDINE	Kenvue Brands LLC	2854047f-c5c4-43c3-8ef2-5c0a84a307f2	2024-11-11	Warnings	Exact identifier application applno (NDA): 020325 application number: NDA020325 ndc (package): 16837-855-49 ndc (product): 16837-855 ndc11 (package): 16837085549
Maximum Strength PEPCID AC Icy Cool Mint	FAMOTIDINE	Kenvue Brands LLC	0f343092-4fc7-1fff-e063-6294a90aba6e	2024-11-11	Warnings	Exact identifier application applno (NDA): 020325 application number: NDA020325
Pepcid AC	FAMOTIDINE	Lil' Drug Store Products, Inc.	14406cd8-468b-403d-9be2-43decd304214	2024-01-09	Warnings	Exact identifier application applno (NDA): 020325 application number: NDA020325

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5QZO15J2Z8	FAMOTIDINE	76824-35-6	FAMOTIDINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310273	famotidine 20 MG Oral Tablet	PSN	2854047f-c5c4-43c3-8ef2-5c0a84a307f2	23
104094	Pepcid AC 20 MG Oral Tablet	PSN	2854047f-c5c4-43c3-8ef2-5c0a84a307f2	23
104094	famotidine 20 MG Oral Tablet [Pepcid]	SBD	2854047f-c5c4-43c3-8ef2-5c0a84a307f2	23
310273	famotidine 20 MG Oral Tablet	SCD	2854047f-c5c4-43c3-8ef2-5c0a84a307f2	23
104094	Pepcid 20 MG Oral Tablet	SY	2854047f-c5c4-43c3-8ef2-5c0a84a307f2	23
104094	Pepcid AC 20 MG Oral Tablet	SY	2854047f-c5c4-43c3-8ef2-5c0a84a307f2	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16837-855-49	16837085549	1 BOTTLE, PLASTIC in 1 CARTON (16837-855-49) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2003-09-01	0000-00-00	No	No	Current