NDC 69097-375

Tadalafil

Tadalafil

Tadalafil is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Cipla Usa Inc.. The primary component is Tadalafil.

• Product ID: 69097-375_22436b1f-ab64-4984-803e-0ec6cb98d25b
• NDC: 69097-375
• Product Type: Human Prescription Drug
• Proprietary Name: Tadalafil
• Generic Name: Tadalafil
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-03-26
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209539
• Labeler Name: Cipla USA Inc.
• Substance Name: TADALAFIL
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69097-375-02

30 TABLET, FILM COATED in 1 BOTTLE (69097-375-02)

• Marketing Start Date: 2019-03-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69097-375-15 [69097037515]

Tadalafil TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA209539
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-03-26

NDC 69097-375-05 [69097037505]

Tadalafil TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA209539
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-03-26

NDC 69097-375-02 [69097037502]

Tadalafil TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA209539
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-03-26

Drug Details

Active Ingredients

Ingredient	Strength
TADALAFIL	10 mg/1

OpenFDA Data

• SPL SET ID: 07fc5cfc-86c9-46b9-ad5a-8d8638a3fc42
• Manufacturer:
  • Cipla USA Inc.
• UNII:
  • 742SXX0ICT
• RxNorm Concept Unique ID - RxCUI:
  • 484814
  • 402019
  • 757707
  • 403957
• UPC Code:
  • 0369097374020
  • 0369097376024
  • 0369097375027
  • 0369097373023

Pharmacological Class

• Phosphodiesterase 5 Inhibitor [EPC]
• Phosphodiesterase 5 Inhibitors [MoA]
• Phosphodiesterase 5 Inhibitor [EPC]
• Phosphodiesterase 5 Inhibitors [MoA]

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

NDC	Brand Name	Generic Name
0093-3016	Tadalafil	Tadalafil
0093-3017	Tadalafil	Tadalafil
0093-3018	Tadalafil	Tadalafil
0093-3019	Tadalafil	Tadalafil
68180-914	Tadalafil	Tadalafil
68382-896	Tadalafil	Tadalafil
68382-898	Tadalafil	Tadalafil
68382-897	Tadalafil	Tadalafil
68382-899	Tadalafil	Tadalafil
69097-376	Tadalafil	Tadalafil
69097-375	Tadalafil	Tadalafil
69097-373	Tadalafil	Tadalafil
69097-526	Tadalafil	Tadalafil
69097-374	Tadalafil	Tadalafil
69238-1347	Tadalafil	Tadalafil
69238-1346	Tadalafil	Tadalafil
69238-1348	Tadalafil	Tadalafil
69238-1349	Tadalafil	Tadalafil
70771-1476	Tadalafil	Tadalafil
70771-1477	Tadalafil	Tadalafil
70771-1478	Tadalafil	Tadalafil
70771-1475	Tadalafil	Tadalafil
71610-214	Tadalafil	Tadalafil
71610-213	Tadalafil	Tadalafil
13668-568	TADALAFIL	TADALAFIL
13668-566	TADALAFIL	TADALAFIL
13668-567	TADALAFIL	TADALAFIL
13668-565	TADALAFIL	TADALAFIL
13668-581	TADALAFIL	TADALAFIL
16729-370	Tadalafil	Tadalafil
16729-372	Tadalafil	Tadalafil
16729-369	Tadalafil	Tadalafil
27241-123	Tadalafil	Tadalafil
27241-111	Tadalafil	Tadalafil
27241-112	Tadalafil	Tadalafil
29300-289	tadalafil	tadalafil
29300-288	tadalafil	tadalafil
27241-114	Tadalafil	Tadalafil
27241-113	Tadalafil	Tadalafil
31722-646	Tadalafil	Tadalafil
29300-286	tadalafil	tadalafil
31722-645	Tadalafil	Tadalafil
29300-287	tadalafil	tadalafil
31722-643	Tadalafil	Tadalafil
31722-647	Tadalafil	Tadalafil
31722-644	Tadalafil	Tadalafil
35573-411	Tadalafil	Tadalafil
35573-410	Tadalafil	Tadalafil
35573-412	Tadalafil	Tadalafil
35573-409	Tadalafil	Tadalafil