APCAL

Product NDC: 46084-071
11-digit product format: 460840071
Labeler code: 46084
Product ID: 46084-071_8747131c-4c0b-4306-8bd9-b29cefb71296
Type: HUMAN OTC DRUG
Nonproprietary name: Calcium Carbonate and Vitamin D3
Dosage form: TABLET
Route: ORAL
Labeler: A P J Laboratories limited
Application: part331
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-03-01
Marketing end: 0000-00-00
Substance: CALCIUM CARBONATE; CHOLECALCIFEROL
Active strength: 1250 mg/1; [iU]/1
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	46084-071		I	Inactivated by FDA	2026-10-20
excluded package	package	46084-071	46084-071-12	I	Inactivated by FDA	2026-10-20
excluded package	package	46084-071	46084-071-13	I	Inactivated by FDA	2026-10-20
excluded package	package	46084-071	46084-071-14	I	Inactivated by FDA	2026-10-20
excluded package	package	46084-071	46084-071-15	I	Inactivated by FDA	2026-10-20
excluded package	package	46084-071	46084-071-16	I	Inactivated by FDA	2026-10-20

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 3 · 132 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	46084-071-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	46084-071-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	46084-071-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	46084-071-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	46084-071-16	`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	46084-071-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	46084-071-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	46084-071-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	46084-071-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	46084-071-16	`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	46084-071-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	46084-071-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	46084-071-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	46084-071-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	46084-071-16	`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	46084-071-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	46084-071-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	46084-071-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	46084-071-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	46084-071-16	`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	46084-071-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	46084-071-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	46084-071-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	46084-071-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	46084-071-16	`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	46084-071-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	46084-071-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	46084-071-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	46084-071-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	46084-071-16	`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	46084-071-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	46084-071-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	46084-071-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	46084-071-13	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	46084-071-16	`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	46084-071-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	46084-071-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	46084-071-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	46084-071-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	46084-071-16	`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	46084-071-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	46084-071-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	46084-071-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	46084-071-13	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	46084-071-16	`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	46084-071-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	46084-071-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	46084-071-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	46084-071-13	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	46084-071-16	`ad56d346431e…`	`cc804d4bbf1e…`

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
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
46084-071-12	51edd66f-8855-469b-8252-ed0d9e6cdaec
46084-071-13	51edd66f-8855-469b-8252-ed0d9e6cdaec
46084-071-14	51edd66f-8855-469b-8252-ed0d9e6cdaec
46084-071-15	51edd66f-8855-469b-8252-ed0d9e6cdaec
46084-071-16	51edd66f-8855-469b-8252-ed0d9e6cdaec

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
46084-071-12	APCAL	30 in 1 BLISTER PACK	TABLET	30	2
46084-071-13	APCAL	60 in 1 BLISTER PACK	TABLET	60	2
46084-071-14	APCAL	120 in 1 BLISTER PACK	TABLET	120	2
46084-071-15	APCAL	250 in 1 BLISTER PACK	TABLET	250	2
46084-071-16	APCAL	500 in 1 BLISTER PACK	TABLET	500	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CALCIUM CARBONATE	ACTIVE INGREDIENT	H0G9379FGK	APCAL (CALCIUM CARBONATE AND VITAMIN D3) TABLET [A P J LABORATORIES LIMITED]	2
CHOLECALCIFEROL	ACTIVE INGREDIENT	1C6V77QF41	APCAL (CALCIUM CARBONATE AND VITAMIN D3) TABLET [A P J LABORATORIES LIMITED]	2
CARBONATE ION	ACTIVE MOIETY	7UJQ5OPE7D	APCAL (CALCIUM CARBONATE AND VITAMIN D3) TABLET [A P J LABORATORIES LIMITED]	2
CHOLECALCIFEROL	ACTIVE MOIETY	1C6V77QF41	APCAL (CALCIUM CARBONATE AND VITAMIN D3) TABLET [A P J LABORATORIES LIMITED]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	APCAL (CALCIUM CARBONATE AND VITAMIN D3) TABLET [A P J LABORATORIES LIMITED]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	APCAL (CALCIUM CARBONATE AND VITAMIN D3) TABLET [A P J LABORATORIES LIMITED]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	APCAL (CALCIUM CARBONATE AND VITAMIN D3) TABLET [A P J LABORATORIES LIMITED]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	APCAL (CALCIUM CARBONATE AND VITAMIN D3) TABLET [A P J LABORATORIES LIMITED]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	APCAL (CALCIUM CARBONATE AND VITAMIN D3) TABLET [A P J LABORATORIES LIMITED]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	APCAL (CALCIUM CARBONATE AND VITAMIN D3) TABLET [A P J LABORATORIES LIMITED]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	APCAL (CALCIUM CARBONATE AND VITAMIN D3) TABLET [A P J LABORATORIES LIMITED]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	APCAL (CALCIUM CARBONATE AND VITAMIN D3) TABLET [A P J LABORATORIES LIMITED]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46084-071	APCAL (CALCIUM CARBONATE AND VITAMIN D3) TABLET [A P J LABORATORIES LIMITED]	2	Legacy NDC, 5 package rows	20130301_51edd66f-8855-469b-8252-ed0d9e6cdaec.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H0G9379FGK	CALCIUM CARBONATE	471-34-1	CALCIUM CARBONATE
1C6V77QF41	CHOLECALCIFEROL	67-97-0	CHOLECALCIFEROL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1371195	calcium 500 MG / vitamin D3 250 UNT Oral Tablet, as calcium carbonate	PSN	51edd66f-8855-469b-8252-ed0d9e6cdaec	2
1371195	calcium carbonate 1250 MG / cholecalciferol 250 UNT Oral Tablet	SCD	51edd66f-8855-469b-8252-ed0d9e6cdaec	2
1371195	calcium carbonate 1250 MG (calcium 500 MG) / vitamin D3 250 UNT Oral Tablet	SY	51edd66f-8855-469b-8252-ed0d9e6cdaec	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
46084-071-12	46084007112	30 in 1 BLISTER PACK	Historical
46084-071-13	46084007113	60 in 1 BLISTER PACK	Historical
46084-071-14	46084007114	120 in 1 BLISTER PACK	Historical
46084-071-15	46084007115	250 in 1 BLISTER PACK	Historical
46084-071-16	46084007116	500 in 1 BLISTER PACK	Historical