NDC 70710-1543

ZALDYON

Mesalamine

ZALDYON is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Mesalamine.

• Product ID: 70710-1543_3d8c9e18-6688-42be-a135-f2d0a4729dbe
• NDC: 70710-1543
• Product Type: Human Prescription Drug
• Proprietary Name: ZALDYON
• Generic Name: Mesalamine
• Dosage Form: Tablet, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2019-01-17
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203286
• Labeler Name: Zydus Pharmaceuticals (USA) Inc.
• Substance Name: MESALAMINE
• Active Ingredient Strength: 800 mg/1
• Pharm Classes: Aminosalicylate [EPC],Aminosalicylic Acids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 70710-1543-4

10 BLISTER PACK in 1 CARTON (70710-1543-4) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70710-1543-2)

• Marketing Start Date: 2019-01-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70710-1543-4 [70710154304]

ZALDYON TABLET, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA203286
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-17

NDC 70710-1543-8 [70710154308]

ZALDYON TABLET, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA203286
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-17

NDC 70710-1543-2 [70710154302]

ZALDYON TABLET, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA203286
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-17

Drug Details

Active Ingredients

Ingredient	Strength
MESALAMINE	800 mg/1

OpenFDA Data

• SPL SET ID: 89eb4706-c347-4bb8-8f89-394dbdec5cd3
• Manufacturer:
  • Zydus Pharmaceuticals (USA) Inc.
• UNII:
  • 4Q81I59GXC
• RxNorm Concept Unique ID - RxCUI:
  • 2108912
  • 833234

Pharmacological Class

• Aminosalicylate [EPC]
• Aminosalicylic Acids [CS]

NDC Crossover Matching brand name "ZALDYON" or generic name "Mesalamine"

NDC	Brand Name	Generic Name
70710-1543	ZALDYON	ZALDYON
70771-1353	ZALDYON	ZALDYON
0023-5901	Asacol HD	mesalamine
0430-0783	ASACOL HD	mesalamine
0023-5853	Delzicol	mesalamine
0179-0142	Lialda	mesalamine
0093-5907	Mesalamine	Mesalamine
0093-9224	mesalamine	mesalamine
0378-1375	Mesalamine	mesalamine
0378-9230	Mesalamine	mesalamine
0472-1915	Mesalamine	Mesalamine
0037-0066	Rowasa	mesalamine
0037-0022	sfRowasa	mesalamine