Foltrate

Product NDC: 50991-323
Requested package NDC: 50991-323-25
11-digit product format: 509910323
Labeler code: 50991
Product ID: 50991-323_ef34ea98-3e70-32b8-e053-2995a90aef00
Type: HUMAN OTC DRUG
Nonproprietary name: Folic Acid and Cyanocobalamin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Poly Pharmaceuticals, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2010-08-26
Marketing end: 0000-00-00
Substance: CYANOCOBALAMIN; FOLIC ACID
Active strength: 500 ug/1; mg/1
Pharmacologic classes: Vitamin B 12 [CS], Vitamin B12 [EPC]
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	50991-323	50991-323-25	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 · 12 matching rows.

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

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

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50991-323-01	EA - Each	50991-323	5944c5a3-5f74-4246-9433-380d73a5dc97	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CYANOCOBALAMIN	ACTIVE INGREDIENT	P6YC3EG204	FOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]	3
FOLIC ACID	ACTIVE INGREDIENT	935E97BOY8	FOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]	3
CYANOCOBALAMIN	ACTIVE MOIETY	P6YC3EG204	FOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]	3
FOLIC ACID	ACTIVE MOIETY	935E97BOY8	FOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]	3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	FOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	FOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	FOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50991-323	FOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]	9	Legacy NDC	20250213_8959f9b0-6f9f-40fb-91ae-4af459fe3bcc.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P6YC3EG204	CYANOCOBALAMIN	68-19-9	CYANOCOBALAMIN
935E97BOY8	FOLIC ACID	59-30-3	FOLIC ACID

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50991-323-25	50991032325	12 BLISTER PACK in 1 CARTON (50991-323-25) > 2 TABLET, FILM COATED in 1 BLISTER PACK	12 blister pack	2010-08-26	0000-00-00	No	No	Current