Home NDC 53746-101 Gabapentin
Product NDC 53746-101
11-digit product format 537460101
Labeler code 53746
Product ID 53746-101_10e5f9be-7920-4775-801b-e1c32b996410
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gabapentin
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA078428
Marketing category ANDA
Marketing start 2009-11-24
Substance GABAPENTIN
Active strength 100 mg/1
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Gabapentin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GABAPENTIN 100 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 6CW7F3G59X Rxcui 310430, 310431, 310432
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53746-101-01 Gabapentin 100 in 1 BOTTLE CAPSULE 100 37 53746-101-05 Gabapentin 500 in 1 BOTTLE CAPSULE 500 37 53746-101-10 Gabapentin 1000 in 1 BOTTLE CAPSULE 1000 37 53746-101-30 Gabapentin 30 in 1 BOTTLE CAPSULE 30 37
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GABAPENTIN ACTIVE INGREDIENT 6CW7F3G59X GABAPENTIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 26 GABAPENTIN ACTIVE MOIETY 6CW7F3G59X GABAPENTIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 26 GABAPENTIN ACTIVE INGREDIENT 6CW7F3G59X GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 8 GABAPENTIN ACTIVE MOIETY 6CW7F3G59X GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 8 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 8 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 8 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 8 GELATIN INACTIVE INGREDIENT 2G86QN327L GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 8 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 8 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 8 TALC INACTIVE INGREDIENT 7SEV7J4R1U GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 8 GABAPENTIN ACTIVE INGREDIENT 6CW7F3G59X GABAPENTIN CAPSULE [AIDAREX PHARMACEUTICALS LLC] 3 GABAPENTIN ACTIVE INGREDIENT 6CW7F3G59X GABAPENTIN CAPSULE [REBEL DISTRIBUTORS CORP] 3 GABAPENTIN ACTIVE INGREDIENT 6CW7F3G59X GABAPENTIN CAPSULE [STAT RX USA LLC] 3 GABAPENTIN ACTIVE MOIETY 6CW7F3G59X GABAPENTIN CAPSULE [AIDAREX PHARMACEUTICALS LLC] 3 GABAPENTIN ACTIVE MOIETY 6CW7F3G59X GABAPENTIN CAPSULE [STAT RX USA LLC] 3 GABAPENTIN ACTIVE MOIETY 6CW7F3G59X GABAPENTIN CAPSULE [REBEL DISTRIBUTORS CORP] 3 GABAPENTIN ACTIVE INGREDIENT 6CW7F3G59X GABAPENTIN CAPSULE [KELTMAN PHARMACEUTICALS INC.] 1 GABAPENTIN ACTIVE MOIETY 6CW7F3G59X GABAPENTIN CAPSULE [KELTMAN PHARMACEUTICALS INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53746-101 GABAPENTIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 37 Current NDC, Legacy NDC, 4 package rows 20240102_b11dbff5-ceee-4a63-a093-f6efebdc2f6f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53746-101-01 53746010101 100 CAPSULE in 1 BOTTLE (53746-101-01) 100 capsule 2009-11-24 0000-00-00 No No Current 53746-101-05 53746010105 500 CAPSULE in 1 BOTTLE (53746-101-05) 500 capsule 2009-11-24 0000-00-00 No No Current 53746-101-10 53746010110 1000 CAPSULE in 1 BOTTLE (53746-101-10) 1000 capsule 2009-11-24 0000-00-00 No No Current 53746-101-30 53746010130 30 CAPSULE in 1 BOTTLE (53746-101-30) 30 capsule 2009-11-24 0000-00-00 No No Current