NDC 0378-1086

Colchicine

Colchicine

Colchicine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Colchicine.

Product ID0378-1086_0d738ed5-bd51-4476-8796-99c9d88f31a0
NDC0378-1086
Product TypeHuman Prescription Drug
Proprietary NameColchicine
Generic NameColchicine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-11-25
Marketing CategoryANDA / ANDA
Application NumberANDA209470
Labeler NameMylan Pharmaceuticals Inc.
Substance NameCOLCHICINE
Active Ingredient Strength1 mg/1
Pharm ClassesCytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0378-1086-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1086-01)
Marketing Start Date2019-11-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-1086-93 [00378108693]

Colchicine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209470
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-11-25

NDC 0378-1086-01 [00378108601]

Colchicine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209470
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-11-25

Drug Details

Active Ingredients

IngredientStrength
COLCHICINE.6 mg/1

Pharmacological Class

  • Cytochrome P450 3A4 Inhibitors [MoA]
  • P-Glycoprotein Interactions [MoA]
  • Cytochrome P450 3A4 Inhibitors [MoA]
  • P-Glycoprotein Interactions [MoA]

NDC Crossover Matching brand name "Colchicine" or generic name "Colchicine"

NDCBrand NameGeneric Name
0143-3018ColchicineColchicine
0254-2008ColchicineColchicine
0378-1086ColchicineColchicine
0591-2562ColchicineColchicine
0904-6732ColchicineColchicine
0904-7120ColchicineColchicine
16714-039ColchicineColchicine
31722-899ColchicineColchicine
42292-054ColchicineColchicine
43598-372colchicinecolchicine
49884-171Colchicinecolchicine
50090-3465ColchicineColchicine
50268-187ColchicineColchicine
51407-082ColchicineColchicine
59651-455ColchicineColchicine
60687-358ColchicineColchicine
60687-389ColchicineColchicine
67877-589colchicinecolchicine
63629-7422ColchicineColchicine
65162-710ColchicineColchicine
66993-165ColchicineColchicine
70710-1351ColchicineColchicine
70771-1396ColchicineColchicine
67296-1708ColchicineColchicine
71205-310ColchicineColchicine
70010-002ColchicineColchicine
71335-1695colchicinecolchicine
71610-494ColchicineColchicine
71335-1738colchicinecolchicine
63629-8362colchicinecolchicine
13310-119ColcrysColchicine
43353-854ColcrysColchicine
63187-292ColcrysColchicine
59467-318MITIGAREColchicine
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