NDC Code(s) : 27437-051-01, 27437-051-02
Packager : Lupin Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SOLOSEC secnidazole GRANULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27437-051
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SECNIDAZOLE(UNII: R3459K699K)
(SECNIDAZOLE - UNII:R3459K699K) 		SECNIDAZOLE2 g in 4.8 g
Inactive Ingredients
Ingredient Name Strength
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(UNII: P2OM2Q86BI)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:27437-051-011 in 1 BOX, UNIT-DOSE 30/10/2017
12 g in 1 PACKET Type 0: Not a Combination Product
2NDC:27437-051-021 in 1 BOX, UNIT-DOSE 19/03/2019
22 g in 1 PACKET Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209363 10/30/2017

LABELER - Lupin Pharmaceuticals, Inc.(089153071)

REGISTRANT - LUPIN INC.(080038238)

Establishment
Name Address ID/FEI Business Operations
Catalent Pharma Solutions, LLC 825745131 MANUFACTURE(27437-051)

Establishment
Name Address ID/FEI Business Operations
Ropack Inc., 209989631 PACK(27437-051)

Establishment
Name Address ID/FEI Business Operations
Catalent Pharma Solutions, LLC, KY 829672745 MANUFACTURE(27437-051)

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Individual Carton

SOLOSEC ® 2g

secnidazole

NDC 27437-051-01

Oral Granules

1 Unit-of-Use Packet

Rx Only

LUPIN PHARMACEUTICALS, INC.

USUAL DOSAGE: One packet.

Solosec ®granules should be administered as follows:

  • Sprinkle onto applesauce, yogurt or pudding. The granules will not dissolve. Consume all of the granules within 30 minutes.
  • Consume the contents of one packet without chewing or crunching the granules.
  • A glass of water may be taken to aid in swallowing.
  • May be taken at any time with, before or after a meal.

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)

(See USP Controlled Room Temperature).

Manufactured for and Distributed by:

Lupin Pharmaceuticals, Inc.

Baltimore, MD 21202

Marketed by: Exeltis USA, Inc., Florham Park, NJ, 07932

© 2022 Lupin Inc. All Rights Reserved

SOLOSEC® is a registered trademark of Lupin Inc.

SYMBFEU0000001-V3

SOLOSEC ®2g

secnidazole

Rx Only

Image 01

Principal Display Panel - Individual Packet

This packet is contained within

CARTON NDC 27437-051-01

SOLOSEC ®

secnidazole

2g

Oral Granules

Rx Only

LUPIN PHARMACEUTICALS, INC.

USUAL DOSAGE: One packet.

Solosec ® granules should be administered as follows:

  • Sprinkle onto applesauce, yogurt or pudding. The granules will not dissolve. Consume all of the granules within 30 minutes.
  • Consume the contents of one packet without chewing or crunching the granules.
  • A glass of water may be taken to aid in swallowing.
  • May be taken at any time with, before or after a meal.

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). (See USP Controlled Room Temperature).

Manufactured for and Distributed by:

Lupin Pharmaceuticals, Inc.

Baltimore, MD 21202

Marketed by: Exeltis USA, Inc., Florham Park, NJ, 07932

© 2022 Lupin Inc. All Rights Reserved

SOLOSEC® is a registered trademark of Lupin Inc.

SYMBFEU0000001-V3

Image 01

Principal Display Panel - Individual Carton

SOLOSEC® 2g

secnidazole

NDC 27437-051-02

Oral Granules

PROFESSIONAL SAMPLE - NOT FOR SALE

1 Unit-of-Use Packet

Rx Only

LUPIN PHARMACEUTICALS, INC.

USUAL DOSAGE: One packet.

Solosec® granules should be administered as follows:

  • Sprinkle onto applesauce, yogurt or pudding. The granules will not dissolve. Consume all of the granules within 30 minutes.
  • Consume the contents of one packet without chewing or crunching the granules.
  • A glass of water may be taken to aid in swallowing.
  • May be taken at any time with, before or after a meal.

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)

(See USP Controlled Room Temperature).

Manufactured for and Distributed by:

Lupin Pharmaceuticals, Inc.

Baltimore, MD 21202

Marketed by: Exeltis USA, Inc., Florham Park, NJ, 07932

© 2022 Lupin Inc. All Rights Reserved

SOLOSEC® is a registered trademark of Lupin Inc.

SYMBFEU0000001-V3

SOLOSEC ®2g

secnidazole

Rx Only

Image 01

Principal Display Panel - Individual Packet

This packet is contained within

CARTON NDC 27437-051-02

solosec®

secnidazole

2g

Oral Granules

PROFESSIONAL SAMPLE - NOT FOR SALE

Rx Only

LUPIN PHARMACEUTICALS, INC.

USUAL DOSAGE: One packet.

Solosec®granules should be administered as follows:

  • Sprinkle onto applesauce, yogurt or pudding. The granules will not dissolve. Consume all of the granules within 30 minutes.
  • Consume the contents of one packet without chewing or crunching the granules.
  • A glass of water may be taken to aid in swallowing.
  • May be taken at any time with, before or after a meal.

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). (See USP Controlled Room Temperature).

Manufactured for and Distributed by:

Lupin Pharmaceuticals, Inc.

Baltimore, MD 21202

Marketed by: Exeltis USA, Inc., Florham Park, NJ, 07932

© 2022 Lupin Inc. All Rights Reserved

SOLOSEC® is a registered trademark of Lupin Inc.

SYMBFEU0000001-V3

Image 01