Famotidine

Product NDC: 68001-398
Requested package NDC: 68001-398-03
11-digit product format: 680010398
Labeler code: 68001
Product ID: 68001-398_bfda441a-c4ae-7bf3-e053-2a95a90adfe2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: BluePoint Laboratories
Application: ANDA206530
Marketing category: ANDA
Marketing start: 2019-06-19
Substance: FAMOTIDINE
Active strength: 40 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

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
A206530-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22
A206530-002	FAMOTIDINE	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206530-001	AB
A206530-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB		2015-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206530-001	FAMOTIDINE	20MG	TABLET / ORAL	AB		2015-12-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206530-002	FAMOTIDINE	40MG	TABLET / ORAL	AB	RS	2015-12-22	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206530-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206530-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206530-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206530-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206530-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206530-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206530-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206530-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206530-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206530-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206530-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206530-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206530-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206530-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206530-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206530-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206530-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206530-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206530-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206530-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206530-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206530-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206530-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206530-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206530-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206530-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206530-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206530-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206530-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206530-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206530-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206530-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206530-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206530-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206530-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206530-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206530-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206530-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206530-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206530-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FAMOTIDINE	40 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
284245	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
8c7ca3cc-ff90-42a7-9218-554cf15348a3	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	Strength	SPL version
68001-398-00	Famotidine	100 in 1 BOTTLE	TABLET, FILM COATED	100		2
68001-398-03	Famotidine	500 in 1 BOTTLE	TABLET, FILM COATED	500		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-398-00	EA - Each	68001-398	d340c830-299e-45f1-920d-af89b774d235	1	2019-10-07
68001-398-03	EA - Each	68001-398	812472d9-f481-4040-8801-337bacb9fb2d	1	2019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-398	FAMOTIDINE TABLET, FILM COATED [BLUEPOINT LABORATORIES]	2	Current NDC, Legacy NDC, 2 package rows	20210415_8c7ca3cc-ff90-42a7-9218-554cf15348a3.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Unit Dose Solutions, Inc.	54d93bf1-8f9a-981b-e063-6394a90a0fde	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206530 application number: ANDA206530
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	11ce2a78-76ce-44df-afe3-57493498e596	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206530 application number: ANDA206530
Famotidine	FAMOTIDINE	Aurobindo Pharma Limited	b0798337-1a73-415e-8416-613984ce5c65	2025-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206530 application number: ANDA206530
Famotidine	FAMOTIDINE	American Health Packaging	3a583080-6771-4246-a221-2491e9e5d8af	2024-09-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206530 application number: ANDA206530
Famotidine	FAMOTIDINE	Proficient Rx LP	4adb4864-04ac-4cb1-96c2-6196a30ac640	2024-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206530 application number: ANDA206530
Famotidine	FAMOTIDINE	A-S Medication Solutions	d8cfa644-7cad-41b9-82a0-242a783fcbc8	2023-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206530 application number: ANDA206530
Famotidine	FAMOTIDINE	Proficient Rx LP	f32d0929-de22-4bec-9e24-bb549cf2679f	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206530 application number: ANDA206530
Famotidine	FAMOTIDINE	BluePoint Laboratories	8c7ca3cc-ff90-42a7-9218-554cf15348a3	2021-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206530 application number: ANDA206530 ndc (package): 68001-398-03 ndc (product): 68001-398 ndc11 (package): 68001039803

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	8c7ca3cc-ff90-42a7-9218-554cf15348a3	2
284245	famotidine 40 MG Oral Tablet	PSN	8c7ca3cc-ff90-42a7-9218-554cf15348a3	2
310273	famotidine 20 MG Oral Tablet	SCD	8c7ca3cc-ff90-42a7-9218-554cf15348a3	2
284245	famotidine 40 MG Oral Tablet	SCD	8c7ca3cc-ff90-42a7-9218-554cf15348a3	2
284245	famotidine 40 MG Oral Tablet	PSN	26a562c2-386a-b58c-e063-6394a90a7cc5	1
284245	famotidine 40 MG Oral Tablet	SCD	26a562c2-386a-b58c-e063-6394a90a7cc5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-398-03	68001039803	500 TABLET, FILM COATED in 1 BOTTLE (68001-398-03)	2019-06-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Famotidine	Coupler LLC \| Aurobindo Pharma Limited	2024-11-11	HUMAN PRESCRIPTION DRUG LABEL	1
Famotidine	BluePoint Laboratories \| Aurobindo Pharma Limited \| APL Health Care Limited,	2021-04-13	HUMAN PRESCRIPTION DRUG LABEL	2