NDC 16729-422

Tacrolimus

Tacrolimus

Tacrolimus is a Topical Ointment in the Human Prescription Drug category. It is labeled and distributed by Accord Healthcare Inc.. The primary component is Tacrolimus.

Product ID16729-422_8a6edc94-b147-a030-e053-2995a90a5e1b
NDC16729-422
Product TypeHuman Prescription Drug
Proprietary NameTacrolimus
Generic NameTacrolimus
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2019-05-31
Marketing CategoryANDA / ANDA
Application NumberANDA211688
Labeler NameAccord Healthcare Inc.
Substance NameTACROLIMUS
Active Ingredient Strength1 mg/g
Pharm ClassesCalcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 16729-422-01

1 TUBE in 1 CARTON (16729-422-01) > 100 g in 1 TUBE
Marketing Start Date2019-06-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16729-422-10 [16729042210]

Tacrolimus OINTMENT
Marketing CategoryANDA
Application NumberANDA211688
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-05-31

NDC 16729-422-01 [16729042201]

Tacrolimus OINTMENT
Marketing CategoryANDA
Application NumberANDA211688
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-06-05

NDC 16729-422-12 [16729042212]

Tacrolimus OINTMENT
Marketing CategoryANDA
Application NumberANDA211688
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2019-05-31

Drug Details

Active Ingredients

IngredientStrength
TACROLIMUS1 mg/g

Pharmacological Class

  • Calcineurin Inhibitor Immunosuppressant [EPC]
  • Calcineurin Inhibitors [MoA]

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

NDCBrand NameGeneric Name
0093-3428Tacrolimustacrolimus
0093-3429Tacrolimustacrolimus
0168-0416Tacrolimustacrolimus
0168-0417Tacrolimustacrolimus
0378-2045TacrolimusTacrolimus
0378-2046TacrolimusTacrolimus
0378-2047TacrolimusTacrolimus
68084-450TacrolimusTacrolimus
68084-449TacrolimusTacrolimus
68084-451TacrolimusTacrolimus
68462-534TacrolimusTacrolimus
69452-154TacrolimusTacrolimus
69452-155TacrolimusTacrolimus
69452-153TacrolimusTacrolimus
70518-1168TacrolimusTacrolimus
0781-2104TacrolimusTacrolimus
0781-2102TacrolimusTacrolimus
0781-2103TacrolimusTacrolimus
0781-9302TacrolimusTacrolimus
0781-9304TacrolimusTacrolimus
0781-9303TacrolimusTacrolimus
0904-6425TacrolimusTacrolimus
0904-6624TacrolimusTacrolimus
0904-6623TacrolimusTacrolimus
16729-041TacrolimusTacrolimus
16729-043TacrolimusTacrolimus
16729-042TacrolimusTacrolimus
43353-317TacrolimusTacrolimus
43817-423TacrolimusTacrolimus
43817-422TacrolimusTacrolimus
43817-421TacrolimusTacrolimus
45802-390TacrolimusTacrolimus
45802-700TacrolimusTacrolimus
50090-2245TacrolimusTacrolimus
51079-817TacrolimusTacrolimus
51079-818TacrolimusTacrolimus
51079-028TacrolimusTacrolimus
55111-525TacrolimusTacrolimus
55111-526TacrolimusTacrolimus
55111-527TacrolimusTacrolimus
55154-5438TacrolimusTacrolimus
55154-4395TacrolimusTacrolimus
55154-2675TacrolimusTacrolimus
60429-378TacrolimusTacrolimus
60429-377TacrolimusTacrolimus
60429-379TacrolimusTacrolimus
62175-381TacrolimusTacrolimus
62250-665TacrolimusTacrolimus
62175-380TacrolimusTacrolimus
62175-382TacrolimusTacrolimus

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