Vitafol

Product NDC: 0642-0094
Requested package NDC: 0642-0094-01
11-digit product format: 006420094
Labeler code: 0642
Product ID: 0642-0094_0777c9df-4100-45c4-a591-4343901b5347
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CHOLECALCIFEROL, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Cyanocobalamin, Iron, and Iodine
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Exeltis USA, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2014-07-14
Marketing end: 0000-00-00
Substance: CHOLECALCIFEROL; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; LEVOMEFOLATE CALCIUM; CYANOCOBALAMIN; IRON; IODINE
Active strength: 25 ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; ug/1
Pharmacologic classes: Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	0642-0094	0642-0094-01	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 · 11 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…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0642-0094-01	2023-02-14	Vitafol ® -Nano Preconception and Prenatal Supplement
0642-0094-03	2023-02-14	Vitafol ® -Nano Preconception and Prenatal Supplement
0642-0094-01	2022-07-29	Vitafol ® -Nano Preconception and Prenatal Supplement
0642-0094-03	2022-07-29	Vitafol ® -Nano Preconception and Prenatal Supplement
0642-0094-03	2021-06-23	Vitafol ® -Nano Preconception and Prenatal Supplement
0642-0094-30	2021-06-23	Vitafol ® -Nano Preconception and Prenatal Supplement
0642-0094-03	2021-01-29	Vitafol ® -Nano Preconception and Prenatal Supplement
0642-0094-30	2021-01-29	Vitafol ® -Nano Preconception and Prenatal Supplement

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0642-0094-01	EA - Each	0642-0094	dfe7cceb-e94d-40e1-ba74-4185cc10bfd0	1	2022-01-06
0642-0094-30	EA - Each	0642-0094	a00eff40-cb1e-4d4e-afd9-8c3e1d4d4508	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHOLECALCIFEROL	ACTIVE INGREDIENT	1C6V77QF41	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
Cyanocobalamin	ACTIVE INGREDIENT	P6YC3EG204	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
Folic Acid	ACTIVE INGREDIENT	935E97BOY8	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
Iodine	ACTIVE INGREDIENT	9679TC07X4	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
Iron	ACTIVE INGREDIENT	E1UOL152H7	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
Levomefolate Calcium	ACTIVE INGREDIENT	A9R10K3F2F	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
Pyridoxine Hydrochloride	ACTIVE INGREDIENT	68Y4CF58BV	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
Cholecalciferol	ACTIVE MOIETY	1C6V77QF41	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
Cyanocobalamin	ACTIVE MOIETY	P6YC3EG204	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
Folic Acid	ACTIVE MOIETY	935E97BOY8	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
Iodine	ACTIVE MOIETY	9679TC07X4	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
Iron	ACTIVE MOIETY	E1UOL152H7	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
Levomefolic Acid	ACTIVE MOIETY	8S95DH25XC	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
Pyridoxine	ACTIVE MOIETY	KV2JZ1BI6Z	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
.ALPHA.-TOCOPHEROL, DL-	INACTIVE INGREDIENT	7QWA1RIO01	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
SODIUM ASCORBATE	INACTIVE INGREDIENT	S033EH8359	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	VITAFOL NANO (CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, AND IODINE) TABLET, COATED [EVERETT LABORATORIES, INC.]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1C6V77QF41	CHOLECALCIFEROL	67-97-0	CHOLECALCIFEROL
68Y4CF58BV	PYRIDOXINE HYDROCHLORIDE	58-56-0	PYRIDOXINE HYDROCHLORIDE
935E97BOY8	FOLIC ACID	59-30-3	FOLIC ACID
A9R10K3F2F	LEVOMEFOLATE CALCIUM	151533-22-1	LEVOMEFOLATE CALCIUM
P6YC3EG204	CYANOCOBALAMIN	68-19-9	CYANOCOBALAMIN
E1UOL152H7	IRON	7439-89-6	IRON
9679TC07X4	IODINE	7553-56-2	IODINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0642-0094-01	00642009401	30 TABLET, COATED in 1 BOTTLE (0642-0094-01)	2014-07-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vitafol ® -Nano Preconception and Prenatal Supplement	Exeltis USA, Inc.	2023-02-14	HUMAN PRESCRIPTION DRUG LABEL	6