NDC 50436-0370

Tadalafil 5 mg tablet, film coated

On the label: Unit Dose Services. It's a repackaged product: Unit Dose Services rebottles it from Accord Healthcare Inc.'s NDC 16729-370.

Where the pills inside were made

Acme Generics Private Limited

Solan, India · makes it and tests it

Problems found, fixed voluntarily Last FDA inspection Feb 20, 2026. 1 inspection on record.

Intas Pharmaceuticals Limited

Ahmedabad, India · makes it and tests it

Serious problems, FDA action Last FDA inspection Dec 2, 2022. 7 inspections on record, 1 with serious problems.

Repackaging site

• Unit Dose Services, · repackages it and relabels it

Recalls

• Feb 7, 2023 · Class II · Terminated
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: a) P2002522, Exp. Date 4/30/2023; P2005817, P2005816, Exp. Date 10/31/2023; P2203687, Exp. Date 6/30/2025; b) P2002521, Exp. Date 4/30/2023; P2005818, Exp. Date 10/31/2023; P2100075, Exp. Date 12/31/2023; P2100996, P2100997, P2100998, P2100999, Exp. Date 1/31/2024;
• Feb 7, 2023 · Class II · Terminated
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: a) P2002450, Exp. Date 4/30/2023, P2003222, Exp. Date 5/31/2023; P2003223, Exp. Date 5/31/2023; P2003224, Exp. Date 5/31/2023; P2004636, Exp. Date 8/31/2023; P2005035, Exp. Date 8/31/2023; P2005038, Exp. Date 8/31/2023; P2005040, Exp. Date 8/31/2023; P2005039, Exp. Date 8/31/2023; P2005041…
• Feb 7, 2023 · Class II · Terminated
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: a) P2002525, Exp. Date 4/30/2023; P2004442, Exp. Date 7/31/2023; P2005014, Exp. Date 8/31/2023; P2005015, Exp. Date 8/31/2023; P2005016, Exp. Date 8/31/2023; P2005825, Exp. Date 10/31/2023; P2005824, Exp. Date 10/31/2023; P2005826, Exp. Date 10/31/2023; P2100368, Exp. Date 12/31/2023; P210…
• Feb 7, 2023 · Class II · Terminated
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: a) P2002461, Exp. Date 4/30/2023; P2002457, Exp. Date 4/30/2023; P2002460, Exp. Date 4/30/2023; P2002464, Exp. Date 4/30/2023; P2002463, Exp. Date 4/30/2023; P2002462, Exp. Date 4/30/2023; P2002465, Exp. Date 4/30/2023; P2003153, Exp. Date 5/31/2023; P2003155, Exp. Date 5/31/2023; P2003156…

Product details

Generic drug

Tadalafil: see every company that makes it

Form

tablet, film coated

Strength

5 mg

Approval

ANDA ANDA209167

On the market since

Mar 27, 2019

Package NDCs

50436-0370-1 50436-0370-2

Official label

DailyMed (National Library of Medicine), updated Sep 21, 2022

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