Home NDC 50991-323-01 Foltrate
Product NDC 50991-323
Requested package NDC 50991-323-01
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 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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50991-323 50991-323-01 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50991-323 50991-323-01 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50991-323 50991-323-01 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50991-323-01 50991032301 100 TABLET, FILM COATED in 1 BOTTLE (50991-323-01) 2010-08-26 0000-00-00 No No Current