Home NDC 51645-994 Meclizine HCl 25 mg
Product NDC 51645-994
11-digit product format 516450994
Labeler code 51645
Product ID 51645-994_b3dc2b97-9b7b-1ced-e053-2a95a90a403c
Type HUMAN OTC DRUG
Nonproprietary name Meclizine Hydrochloride
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Gemini Pharmaceuticals, Inc. dba Plus Pharma
Application part336
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-10-15
Marketing end 0000-00-00
Substance MECLIZINE HYDROCHLORIDE
Active strength 25 mg/1
NDC exclude flag No
Listing certified through 2021-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MECLIZINE HYDROCHLORIDE ACTIVE INGREDIENT HDP7W44CIO MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 1 MECLIZINE ACTIVE MOIETY 3L5TQ84570 MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 1 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 1 DEXTROSE INACTIVE INGREDIENT IY9XDZ35W2 MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 1 SODIUM SULFATE INACTIVE INGREDIENT 0YPR65R21J MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 1 TRICALCIUM PHOSPHATE INACTIVE INGREDIENT K4C08XP666 MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [GEMINI PHARMACEUTICALS, INC. DBA PLUS PHARMA] 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 51645-994-01 51645099401 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (51645-994-01) 2015-10-15 0000-00-00 No No Current 51645-994-10 51645099410 1000 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (51645-994-10) 2015-10-15 0000-00-00 No No Current