Foltrate

Product NDC
50991-323
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50991-323DDiscontinued by firm2026-09-14
excluded packagepackage50991-32350991-323-01DDiscontinued by firm2026-09-14
excluded packagepackage50991-32350991-323-25DDiscontinued by firm2026-09-14

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50991-323-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50991-323-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50991-323-252ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50991-323-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50991-323-25cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50991-323-25cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50991-323-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50991-323-25302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50991-323-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50991-323-25ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50991-323-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50991-323-250efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50991-323-25ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50991-323-25367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50991-323-25557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50991-323-01EA - Each50991-3235944c5a3-5f74-4246-9433-380d73a5dc9712014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG204FOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]3
FOLIC ACIDACTIVE INGREDIENT935E97BOY8FOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]3
CYANOCOBALAMINACTIVE MOIETYP6YC3EG204FOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]3
FOLIC ACIDACTIVE MOIETY935E97BOY8FOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JFOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50991-323FOLTRATE (FOLIC ACID AND CYANOCOBALAMIN) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.]9Legacy NDC20250213_8959f9b0-6f9f-40fb-91ae-4af459fe3bcc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50991-323-0150991032301100 TABLET, FILM COATED in 1 BOTTLE (50991-323-01) 2010-08-260000-00-00NoNoCurrent
50991-323-255099103232512 BLISTER PACK in 1 CARTON (50991-323-25) > 2 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2010-08-260000-00-00NoNoCurrent