Home NDC 60429-204 Meclizine Hydrochloride
Product NDC 60429-204
11-digit product format 604290204
Labeler code 60429
Product ID 60429-204_79f3f684-da4e-a36e-e053-2991aa0a0408
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name meclizine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA087127
Marketing category ANDA
Marketing start 2012-04-02
Marketing end 0000-00-00
Substance MECLIZINE HYDROCHLORIDE
Active strength 13 mg/1
Pharmacologic classes Antiemetic [EPC],Emesis Suppression [PE]
NDC exclude flag No
Listing certified through 2020-12-31
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.
Source provenance: Browse the complete Orange Book source catalog .
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2019-12-13 00:20 UTC 2019-12 A087127-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 74a2ff9319b5…2020-11-12 02:37 UTC 2020-11 A087127-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A087127-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A087127-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A087127-001 MECLIZINE HYDROCHLORIDE 12.5MG TABLET / ORAL AA Approved before 1982 ea99ee380514…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MECLIZINE HYDROCHLORIDE ACTIVE INGREDIENT HDP7W44CIO MECLIZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 MECLIZINE ACTIVE MOIETY 3L5TQ84570 MECLIZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK MECLIZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MECLIZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G MECLIZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD MECLIZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M MECLIZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 MECLIZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MECLIZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MECLIZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 MECLIZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MECLIZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP MECLIZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R MECLIZINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1