Calcium carbonate

Product NDC: 0536-3414
11-digit product format: 005363414
Labeler code: 0536
Product ID: 0536-3414_072d6298-0d2b-476e-bb53-eee6dac12127
Type: HUMAN OTC DRUG
Nonproprietary name: Calcium carbonate
Dosage form: TABLET
Route: ORAL
Labeler: Rugby Laboratories Inc.
Application: part331
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 1999-04-12
Marketing end: 0000-00-00
Substance: CALCIUM CARBONATE
Active strength: 648 mg/1
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0536-3414		D	Discontinued by firm		2026-10-05
excluded package	package	0536-3414	0536-3414-10	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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0536-3414-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0536-3414-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0536-3414-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0536-3414-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0536-3414-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0536-3414-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0536-3414-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0536-3414-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0536-3414-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0536-3414-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0536-3414-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0536-3414-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99	Product name	1	20250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767	Product name	4	20250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
334fe8d2-68fb-4331-a576-420e302ec069	Product name	7	20240320
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
e92765c1-be81-432a-b909-1b10777ec378	Product name	1	20190208
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
0441a8f5-3835-497c-aedd-bc78cba56b2a	Product name	1	20150317
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-3414-10	EA - Each	0536-3414	2eca9d4c-10ae-4d1d-9d8f-7a71c4e920b7	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CALCIUM CARBONATE	ACTIVE INGREDIENT	H0G9379FGK	CALCIUM CARBONATE TABLET [CARILION MATERIALS MANAGEMENT]	2
CALCIUM CARBONATE	ACTIVE INGREDIENT	H0G9379FGK	CALCIUM CARBONATE TABLET [RUGBY LABORATORIES INC.]	2
CARBONATE ION	ACTIVE MOIETY	7UJQ5OPE7D	CALCIUM CARBONATE TABLET [CARILION MATERIALS MANAGEMENT]	2
CARBONATE ION	ACTIVE MOIETY	7UJQ5OPE7D	CALCIUM CARBONATE TABLET [RUGBY LABORATORIES INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CALCIUM CARBONATE TABLET [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CALCIUM CARBONATE TABLET [RUGBY LABORATORIES INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CALCIUM CARBONATE TABLET [CARILION MATERIALS MANAGEMENT]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CALCIUM CARBONATE TABLET [RUGBY LABORATORIES INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CALCIUM CARBONATE TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CALCIUM CARBONATE TABLET [RUGBY LABORATORIES INC.]	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	CALCIUM CARBONATE TABLET [CARILION MATERIALS MANAGEMENT]	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	CALCIUM CARBONATE TABLET [RUGBY LABORATORIES INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	CALCIUM CARBONATE TABLET [CARILION MATERIALS MANAGEMENT]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	CALCIUM CARBONATE TABLET [RUGBY LABORATORIES INC.]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H0G9379FGK	CALCIUM CARBONATE	471-34-1	CALCIUM CARBONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
577040	calcium carbonate 648 MG (Ca 260 MG) Oral Tablet	PSN	1cd621d0-58b9-45f7-80fb-e13ca68596a1	2
577040	calcium carbonate 648 MG Oral Tablet	SCD	1cd621d0-58b9-45f7-80fb-e13ca68596a1	2
577040	calcium carbonate 648 MG (as calcium 260 MG) Oral Tablet	SY	1cd621d0-58b9-45f7-80fb-e13ca68596a1	2

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Calcium Carbonate Tablets	Carilion Materials Management	2012-12-13	HUMAN OTC DRUG LABEL	2
Calcium Carbonate Tablets	Rugby Laboratories Inc. \| Advance Pharmaceutical Inc.	2012-12-13	HUMAN OTC DRUG LABEL	2