Prescription Drug Information: Bethanechol Chloride (Page 2 of 2)

PRINCIPAL DISPLAY PANEL — 25 mg Container Label

NDC 0527-1356 -01

Bethanechol
Chloride
Tablets, USP

25 mg

Rx Only

100 Tablets

Lannett

25 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg Container Label

NDC 0527-1329 -01

Bethanechol
Chloride
Tablets, USP

50 mg

Rx Only

100 Tablets

Lannett

50 mg
(click image for full-size original)
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1332
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (BETHANECHOL) BETHANECHOL CHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE B POTATO
SILICON DIOXIDE
TALC
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (off-white) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code LCI;1332
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-1332-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040677 03/27/2008
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1340
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (BETHANECHOL) BETHANECHOL CHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE B POTATO
SILICON DIOXIDE
TALC
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (off-white) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code LCI;1340
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-1340-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040677 03/27/2008
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1356
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (BETHANECHOL) BETHANECHOL CHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE B POTATO
SILICON DIOXIDE
TALC
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (off-white) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code LCI;1356
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-1356-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040677 03/27/2008
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1329
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (BETHANECHOL) BETHANECHOL CHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE B POTATO
SILICON DIOXIDE
TALC
MAGNESIUM STEARATE
D&C YELLOW NO. 10
ALUMINUM OXIDE
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code LCI;1329
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-1329-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040677 03/27/2008
Labeler — Lannett Company, Inc. (002277481)
Establishment
Name Address ID/FEI Operations
Lannett Company, Inc. 829757603 ANALYSIS (0527-1332), ANALYSIS (0527-1340), ANALYSIS (0527-1356), ANALYSIS (0527-1329)
Establishment
Name Address ID/FEI Operations
Lannett Company, Inc. 006422406 LABEL (0527-1332), LABEL (0527-1340), LABEL (0527-1356), LABEL (0527-1329), MANUFACTURE (0527-1332), MANUFACTURE (0527-1340), MANUFACTURE (0527-1356), MANUFACTURE (0527-1329), PACK (0527-1332), PACK (0527-1340), PACK (0527-1356), PACK (0527-1329), RELABEL (0527-1332), RELABEL (0527-1340), RELABEL (0527-1356), RELABEL (0527-1329), REPACK (0527-1332), REPACK (0527-1340), REPACK (0527-1356), REPACK (0527-1329)

Revised: 03/2020 Lannett Company, Inc.

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