famotidine

Product NDC: 69230-326
Requested package NDC: 69230-326-33
11-digit product format: 692300326
Labeler code: 69230
Product ID: 69230-326_eabd2ff8-a7d9-2ac4-e053-2995a90a3b40
Type: HUMAN OTC DRUG
Nonproprietary name: famotidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Camber Consumer Care Inc
Application: ANDA215766
Marketing category: ANDA
Marketing start: 2021-11-08
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: 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
unfinished package	package	69230-326	69230-326-33	UNFINISHED	Active or certified unfinished drug listing		2026-08-07

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 · 7 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 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`

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
A215766-001	FAMOTIDINE	FAMOTIDINE	10MG	TABLET / ORAL			2021-11-08
A215766-002	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL			2021-11-08

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 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215766-001	FAMOTIDINE	10MG	TABLET / ORAL	2021-11-08	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215766-002	FAMOTIDINE	20MG	TABLET / ORAL	2021-11-08	`6a51e52b5d6a…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FAMOTIDINE	10 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
199047	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
ebe3ca30-df25-4c56-8935-414a3431b5b9	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69230-326-01	famotidine	1 in 1 CARTON	TABLET, FILM COATED	1	2
69230-326-01	famotidine	100 in 1 BOTTLE	TABLET, FILM COATED	100	2
69230-326-05	famotidine	500 in 1 BOTTLE	TABLET, FILM COATED	500	2
69230-326-05	famotidine	1 in 1 CARTON	TABLET, FILM COATED	1	2
69230-326-10	famotidine	1 in 1 CARTON	TABLET, FILM COATED	1	2
69230-326-10	famotidine	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	2
69230-326-30	famotidine	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
69230-326-30	famotidine	1 in 1 CARTON	TABLET, FILM COATED	1	2
69230-326-60	famotidine	1 in 1 CARTON	TABLET, FILM COATED	1	2
69230-326-60	famotidine	60 in 1 BOTTLE	TABLET, FILM COATED	60	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69230-326-01	EA - Each	69230-326	518bb868-14fc-4091-afc7-07ea90dfc570	1	2022-11-07
69230-326-05	EA - Each	69230-326	a1f54079-51ca-46df-9d83-cd10852434ba	1	2022-11-07
69230-326-10	EA - Each	69230-326	d7453e8d-c651-4d46-a240-779bdbe47171	1	2022-11-07
69230-326-30	EA - Each	69230-326	0512ff0b-532f-4e4e-8e08-7cc65f73afc7	1	2022-11-07
69230-326-60	EA - Each	69230-326	f29b8820-844e-4ff6-ab07-497a990dcd80	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69230-326	FAMOTIDINE (FAMOTIDINE) TABLET, FILM COATED [CAMBER CONSUMER CARE INC]	2	Current NDC, Legacy NDC, 10 package rows	20221012_ebe3ca30-df25-4c56-8935-414a3431b5b9.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Goodmeds Famotidine 20mg 500 count	FAMOTIDINE 20MG	Cabinet Health P.B.C.	5592d0f0-03fd-c914-e063-6294a90a2826	2026-07-01	Warnings	Exact identifier application applno (ANDA): 215766 application number: ANDA215766
Heartburn Relief	FAMOTIDINE	Shield Pharmaceuticals Corp	a12ec91d-244f-45c5-8590-d1e4485fe361	2025-10-31	Warnings	Exact identifier application applno (ANDA): 215766 application number: ANDA215766
Famotidine	FAMOTIDINE	Little Pharma, Inc.	33dc93a5-ee03-2e68-e063-6294a90aeee1	2025-07-05	Warnings	Exact identifier application applno (ANDA): 215766 application number: ANDA215766
famotidine	FAMOTIDINE	CHAIN DRUG MARKETING ASSOCIATION, INC.	6daf1ebe-b0a2-4413-bf25-3de6eb64b0c6	2024-03-27	Warnings	Exact identifier application applno (ANDA): 215766 application number: ANDA215766
famotidine	FAMOTIDINE	Camber Consumer Care Inc	ebe3ca30-df25-4c56-8935-414a3431b5b9	2022-10-11	Warnings	Exact identifier application applno (ANDA): 215766 application number: ANDA215766 ndc (product): 69230-326

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
199047	famotidine 10 MG Oral Tablet	PSN	ebe3ca30-df25-4c56-8935-414a3431b5b9	2
310273	famotidine 20 MG Oral Tablet	PSN	ebe3ca30-df25-4c56-8935-414a3431b5b9	2
199047	famotidine 10 MG Oral Tablet	SCD	ebe3ca30-df25-4c56-8935-414a3431b5b9	2
310273	famotidine 20 MG Oral Tablet	SCD	ebe3ca30-df25-4c56-8935-414a3431b5b9	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
69230-326-33	69230032633	7 POUCH in 1 DRUM (69230-326-33) / 10000 TABLET, FILM COATED in 1 POUCH	7 pouch	08-NOV-21	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Famotidine tablets USP, 10 mg and 20 mg	Camber Consumer Care Inc \| Annora Pharma Private Limited	2022-10-11	HUMAN OTC DRUG LABEL	2