equaline complete

Product NDC: 41163-546
Requested package NDC: 41163-546-63
11-digit product format: 411630546
Labeler code: 41163
Product ID: 41163-546_1f2ed065-778d-498d-ac66-711a7b47699e
Type: HUMAN OTC DRUG
Nonproprietary name: Famotidine, Calcium Carbonate, Magnesium Hydroxide
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Supervalu Inc
Application: ANDA077355
Marketing category: ANDA
Marketing start: 2008-09-02
Marketing end: 0000-00-00
Substance: CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE
Active strength: 800 mg/1; mg/1; mg/1
Pharmacologic classes: Calculi Dissolution Agent [EPC], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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	41163-546	41163-546-63	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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL			2008-02-06

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 · 41 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	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077355-001	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	800MG;10MG;165MG	TABLET, CHEWABLE / ORAL	2008-02-06	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
41163-546-63	2022-07-19	SuperValu Inc. Dual Action Complete Drug Facts
41163-546-71	2022-07-19	SuperValu Inc. Dual Action Complete Drug Facts
41163-546-63	2021-07-23	SuperValu Inc. Dual Action Complete Drug Facts
41163-546-71	2021-07-23	SuperValu Inc. Dual Action Complete Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
41163-546-63	EA - Each	41163-546	70ef7acc-8ac7-409b-9fe1-1cc3a13d3ab8	1	2017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CALCIUM CARBONATE	ACTIVE INGREDIENT	H0G9379FGK	EQUALINE COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [SUPERVALU INC]	3
FAMOTIDINE	ACTIVE INGREDIENT	5QZO15J2Z8	EQUALINE COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [SUPERVALU INC]	3
MAGNESIUM HYDROXIDE	ACTIVE INGREDIENT	NBZ3QY004S	EQUALINE COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [SUPERVALU INC]	3
CALCIUM CATION	ACTIVE MOIETY	2M83C4R6ZB	EQUALINE COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [SUPERVALU INC]	3
FAMOTIDINE	ACTIVE MOIETY	5QZO15J2Z8	EQUALINE COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [SUPERVALU INC]	3
HYDROXIDE ION	ACTIVE MOIETY	9159UV381P	EQUALINE COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [SUPERVALU INC]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	EQUALINE COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [SUPERVALU INC]	3
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	EQUALINE COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [SUPERVALU INC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	EQUALINE COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [SUPERVALU INC]	3
DEXTRATES	INACTIVE INGREDIENT	G263MI44RU	EQUALINE COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [SUPERVALU INC]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	EQUALINE COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [SUPERVALU INC]	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	EQUALINE COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [SUPERVALU INC]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	EQUALINE COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [SUPERVALU INC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	EQUALINE COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [SUPERVALU INC]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	EQUALINE COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [SUPERVALU INC]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	EQUALINE COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [SUPERVALU INC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	EQUALINE COMPLETE DUAL ACTION (FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [SUPERVALU INC]	3

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 2 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DUAL ACTION COMPLETE	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Amazon.com Services LLC	4e8a936c-b876-4923-ad9e-d23537b5d7cf	2026-07-28	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
COMPLETE ACID REDUCER	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	962ced24-0fb3-4aba-b32e-2e6fa1c1c5d7	2026-07-22	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
Good Neighbor Pharmacy Dual Action Complete	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Amerisource Bergen	b7453c0e-b452-409b-a324-83fdd105bfd0	2026-06-02	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
Dual Action Complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	Meijer Distribution Inc	50fe57e1-6678-4697-9b35-4673db67d4fb	2026-06-01	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
COMPLETE ACID REDUCER	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	6ccc03bd-3f36-452a-8945-b3d71cce8241	2026-04-08	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
Acid Reducer Plus Antacid	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Rite Aid Corporation	5490abe2-11f0-45a8-aefa-f70263ff1da8	2026-03-27	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
GOOD SENSE DUAL ACTION COMPLETE	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	L. Perrigo Company	b5a36da3-7316-493c-b50f-fc5393d858c0	2026-03-24	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
ACID REDUCER COMPLETE	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	Walgreen Company	b94b16d3-b52f-4d70-bbb0-d9fb074c891c	2026-03-19	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
complete dual action	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	HyVee Inc	237efe92-b302-4e11-93fe-7b0f727a00aa	2026-03-12	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
Acid Reducer Complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	Walgreen Company	6f1dcfda-c12a-4c3b-80a2-c9e15517c88f	2026-03-03	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
Dual Action Complete	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Meijer Distribution Inc	6e8ed233-9ffb-46f7-9632-d5bc3d3a558b	2026-01-20	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
equaline complete dual action	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	United Natural Foods, Inc. dba UNFI	c32cb5be-e1f8-4510-8685-5e03a7d4224c	2026-01-13	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
Good Sense Dual Action Complete	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	L. Perrigo Company	b7154648-8c8c-4ce6-88b7-5442a16143c5	2025-11-14	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
acid reducer complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	Safeway	4f0a178c-d0ed-4bbc-a8ce-fda3789d25f0	2025-10-14	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
Up and Up Dual Action Acid Reducer and Antacid	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	Target Corporation	2f020677-77a0-4e13-9397-e9deeda63293	2025-09-10	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
topcare dual action complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	Topco Associates LLC	2c5a1694-d6e9-4679-b421-61eaad5403a4	2025-09-04	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
CareOne Acid Reducer Complete	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	American Sales Company	5d4bea42-25d5-4943-b5ed-471eccd36bf8	2025-08-29	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
CareOne Acid Reducer Complete	FAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDE	American Sales Company	19045840-2d25-43af-8c92-f36c8b903b28	2025-08-28	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
ACID REDUCER COMPLETE	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Safeway	484ad323-82cf-4157-bacb-236af8210c87	2025-08-27	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355
dual action complete	FAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE	Publix Super Markets Inc	913073fe-22ce-40a3-ad22-bf3027c21e99	2025-08-14	Warnings	Exact identifier application applno (ANDA): 077355 application number: ANDA077355

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H0G9379FGK	CALCIUM CARBONATE	471-34-1	CALCIUM CARBONATE
5QZO15J2Z8	FAMOTIDINE	76824-35-6	FAMOTIDINE
NBZ3QY004S	MAGNESIUM HYDROXIDE	1309-42-8	MAGNESIUM HYDROXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
41163-546-63	41163054663	25 TABLET, CHEWABLE in 1 BOTTLE (41163-546-63)	2008-09-02	0000-00-00	No	No	Current