NDC Code(s) : 24979-200-01, 24979-200-02, 24979-200-03
Packager : TWi Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dicyclomine HydrochlorideDicyclomine Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24979-200
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICYCLOMINE HYDROCHLORIDE(UNII: CQ903KQA31)
(DICYCLOMINE - UNII:4KV4X8IF6V) 		DICYCLOMINE HYDROCHLORIDE20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STEARIC ACID(UNII: 4ELV7Z65AP)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code T;200
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24979-200-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/01/2023
2NDC:24979-200-02500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/01/2023
3NDC:24979-200-031000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/01/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216782 07/01/2023

LABELER - TWi Pharmaceuticals, Inc.(658402052)

REGISTRANT - TWi Pharmaceuticals, Inc.(658402052)

Establishment
Name Address ID/FEI Business Operations
TWi Pharmaceuticals, Inc. Zhongli Plant 658863394 manufacture(24979-200), analysis(24979-200), pack(24979-200)

Establishment
Name Address ID/FEI Business Operations
BORA PHARMACEUTICAL LABORATORIES INC. 656139511 manufacture(24979-200), analysis(24979-200), pack(24979-200)

PRINCIPAL DISPLAY PANEL

NDC 24979-200-01

Dicyclomine Hydrochloride Tablets, USP

20 mg

Rx only

100 Tablets

TWi

image description

PRINCIPAL DISPLAY PANEL

NDC 24979-200-03

Dicyclomine Hydrochloride Tablets, USP

20 mg

Rx only

1000 Tablets

TWi

image description