FAMOTIDINE

Product NDC: 70518-3829
11-digit product format: 705183829
Labeler code: 70518
Product ID: 70518-3829_53d3403f-783c-f424-e063-6294a90a64ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FAMOTIDINE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA215630
Marketing category: ANDA
Marketing start: 2023-08-15
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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-3829	70518-3829-0	D	Discontinued by firm		2026-10-05
excluded package	package	70518-3829	70518-3829-2	D	Discontinued by firm		2026-10-05

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 · 12 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	70518-3829-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	70518-3829-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	70518-3829-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	70518-3829-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	70518-3829-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	70518-3829-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	70518-3829-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	70518-3829-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	70518-3829-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	70518-3829-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	70518-3829-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	70518-3829-0	`ad56d346431e…`	`cc804d4bbf1e…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A215630-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL	AB		2022-01-07
A215630-002	FAMOTIDINE	FAMOTIDINE	40MG	TABLET / ORAL	AB		2022-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215630-001	AB
A215630-002	AB

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 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215630-001	FAMOTIDINE	20MG	TABLET / ORAL	AB	2022-01-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215630-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	2022-01-07	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215630-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215630-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215630-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215630-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215630-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215630-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215630-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215630-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215630-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215630-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215630-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215630-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215630-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215630-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215630-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215630-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215630-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215630-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215630-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215630-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215630-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215630-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215630-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215630-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215630-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215630-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215630-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215630-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215630-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215630-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215630-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215630-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215630-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215630-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215630-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A215630-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215630-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A215630-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215630-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A215630-002	AB	1	`bb7c543d1eb4…`

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: FAMOTIDINE
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
e59a2c97-19c7-485c-bb1b-272ddb9ae053	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
70518-3829-0	FAMOTIDINE	50 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	50	13
70518-3829-1	FAMOTIDINE	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	13
70518-3829-2	FAMOTIDINE	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	13
70518-3829-3	FAMOTIDINE	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	13
70518-3829-4	FAMOTIDINE	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	13
70518-3829-5	FAMOTIDINE	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	13
70518-3829-6	FAMOTIDINE	14 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	14	13
70518-3829-7	FAMOTIDINE	60 in 1 BLISTER PACK	TABLET, FILM COATED	60	13
70518-3829-8	FAMOTIDINE	14 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	14	13
70518-3829-9	FAMOTIDINE	25 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	25	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3829	FAMOTIDINE TABLET, FILM COATED [REMEDYREPACK INC.]	10	Current NDC, 10 package rows	20250115_e59a2c97-19c7-485c-bb1b-272ddb9ae053.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 2 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FAMOTIDINE	FAMOTIDINE	NuCare Pharmaceuticals,Inc.	13168d9e-0697-e5fb-e063-6294a90a69ba	2024-03-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630
FAMOTIDINE	FAMOTIDINE	Ascend Laboratories, LLC	ea50552f-f9b9-467f-a925-62ff027df607	2023-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215630 application number: ANDA215630

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	e59a2c97-19c7-485c-bb1b-272ddb9ae053	13
310273	famotidine 20 MG Oral Tablet	SCD	e59a2c97-19c7-485c-bb1b-272ddb9ae053	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70518-3829-0	70518382900	50 in 1 BOTTLE, PLASTIC				Historical
70518-3829-1	70518382901	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3829-1)	2023-11-06	No	No	Current
70518-3829-2	70518382902	60 in 1 BOTTLE, PLASTIC				Historical
70518-3829-3	70518382903	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3829-3)	2024-01-24	No	No	Current
70518-3829-4	70518382904	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3829-4)	2024-02-28	No	No	Current
70518-3829-5	70518382905	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3829-5)	2024-06-12	No	No	Current
70518-3829-6	70518382906	14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3829-6)	2024-11-21	No	No	Current
70518-3829-7	70518382907	60 TABLET, FILM COATED in 1 BLISTER PACK (70518-3829-7)	2025-01-04	No	No	Current
70518-3829-8	70518382908	14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3829-8)	2025-01-14	No	No	Current
70518-3829-9	70518382909	25 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3829-9)	2025-10-15	No	No	Current