NDC 10631-099

Lac Hydrin Cream

Ammonium Lactate

Lac Hydrin Cream is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Ranbaxy Laboratories Inc.. The primary component is Ammonium Lactate.

• Product ID: 10631-099_807054c6-2dae-4cc2-b790-674ab66cf79b
• NDC: 10631-099
• Product Type: Human Prescription Drug
• Proprietary Name: Lac Hydrin Cream
• Generic Name: Ammonium Lactate
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2009-03-16
• Marketing Category: NDA / NDA
• Application Number: NDA020508
• Labeler Name: Ranbaxy Laboratories Inc.
• Substance Name: AMMONIUM LACTATE
• Active Ingredient Strength: 120 mg/g
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 10631-099-28

140 g in 1 TUBE (10631-099-28)

• Marketing Start Date: 2009-03-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 10631-099-28 [10631009928]

Lac Hydrin Cream CREAM

• Marketing Category: NDA
• Application Number: NDA020508
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2009-03-16
• Marketing End Date: 2014-02-28

NDC 10631-099-38 [10631009938]

Lac Hydrin Cream CREAM

• Marketing Category: NDA
• Application Number: NDA020508
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2009-03-16
• Marketing End Date: 2013-02-28

Drug Details

Active Ingredients

Ingredient	Strength
AMMONIUM LACTATE	120 mg/g

OpenFDA Data

• SPL SET ID: 807054c6-2dae-4cc2-b790-674ab66cf79b
• Manufacturer:
  • Ranbaxy Laboratories Inc.
• UNII:
  • 67M901L9NQ
• RxNorm Concept Unique ID - RxCUI:
  • 543464
  • 543460

NDC Crossover Matching brand name "Lac Hydrin Cream" or generic name "Ammonium Lactate"

NDC	Brand Name	Generic Name
45802-419	Ammonium Lactate	Ammonium Lactate
45802-493	Ammonium Lactate	Ammonium Lactate
51672-1300	Ammonium Lactate	Ammonium Lactate
51672-1301	Ammonium Lactate	Ammonium Lactate
63044-404	Ammonium Lactate	Ammonium Lactate
63044-484	Ammonium Lactate	Ammonium Lactate
63629-8608	Ammonium Lactate	Ammonium Lactate
63629-8609	Ammonium Lactate	Ammonium Lactate
63629-8610	Ammonium Lactate	Ammonium Lactate
63629-8611	Ammonium Lactate	Ammonium Lactate
70518-2449	Ammonium Lactate	Ammonium Lactate
10631-099	Lac Hydrin	ammonium lactate