NDC 43063-045

Dicyclomine Hydrochloride

Dicyclomine Hydrochloride

Dicyclomine Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, In. The primary component is Dicyclomine Hyd.

• Product ID: 43063-045_808969fc-5f43-a27f-e053-2a91aa0a6c75
• NDC: 43063-045
• Product Type: Human Prescription Drug
• Proprietary Name: Dicyclomine Hydrochloride
• Generic Name: Dicyclomine Hydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 1986-07-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA085223
• Labeler Name: PD-Rx Pharmaceuticals, In
• Substance Name: DICYCLOMINE HYD
• Active Ingredient Strength: 20 mg/1
• Pharm Classes: Anticholinergic
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 43063-045-04

4 TABLET in 1 BOTTLE, PLASTIC (43063-045-04)

• Marketing Start Date: 2008-12-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43063-045-04 [43063004504]

Dicyclomine Hydrochloride TABLET

• Marketing Category: ANDA
• Application Number: ANDA085223
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-12-22

NDC 43063-045-60 [43063004560]

Dicyclomine Hydrochloride TABLET

• Marketing Category: ANDA
• Application Number: ANDA085223
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-04-14

NDC 43063-045-30 [43063004530]

Dicyclomine Hydrochloride TABLET

• Marketing Category: ANDA
• Application Number: ANDA085223
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-08-07

NDC 43063-045-20 [43063004520]

Dicyclomine Hydrochloride TABLET

• Marketing Category: ANDA
• Application Number: ANDA085223
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-09-17

NDC 43063-045-06 [43063004506]

Dicyclomine Hydrochloride TABLET

• Marketing Category: ANDA
• Application Number: ANDA085223
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-09-17

Drug Details

Active Ingredients

Ingredient	Strength
DICYCLOMINE HYDROCHLORIDE	20 mg/1

OpenFDA Data

• SPL SET ID: da0e1f63-cb90-4c2a-908f-7d81e672be10
• Manufacturer:
  • PD-Rx Pharmaceuticals, Inc.
• UNII:
  • CQ903KQA31
• RxNorm Concept Unique ID - RxCUI:
  • 991086
• UPC Code:
  • 0343063045305

Pharmacological Class

• Anticholinergic [EPC]
• Cholinergic Antagonists [MoA]

NDC Crossover Matching brand name "Dicyclomine Hydrochloride" or generic name "Dicyclomine Hydrochloride"

NDC	Brand Name	Generic Name
0054-0622	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
0143-3126	Dicyclomine hydrochloride	Dicyclomine hydrochloride
0378-1610	Dicyclomine Hydrochloride	dicyclomine hydrochloride
0378-1620	Dicyclomine Hydrochloride	dicyclomine hydrochloride
0440-7384	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
0517-1980	Dicyclomine hydrochloride	Dicyclomine hydrochloride
0527-0586	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
0527-1282	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
0591-0794	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
0591-0795	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
0603-1161	dicyclomine hydrochloride	dicyclomine hydrochloride
0615-7754	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
0615-7755	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
0641-6173	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
0904-6969	Dicyclomine hydrochloride	Dicyclomine hydrochloride
0904-6987	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
0904-6988	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
10135-520	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
10544-560	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
68071-3310	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
68071-1908	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
68071-3035	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
68071-3255	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
68071-4782	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
68083-320	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE
68151-1161	dicyclomine hydrochloride	dicyclomine hydrochloride
68151-2265	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
68788-6404	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
68788-7059	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
68788-6937	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
68788-9291	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
68788-9525	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
68788-9705	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
68788-9935	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
70518-0236	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
70518-0327	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
70518-0100	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
70518-0755	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
70518-0858	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
70518-0302	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
70518-1596	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
70518-1732	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
70518-1767	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
70934-182	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
71205-043	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
71335-0425	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
71335-0588	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
71335-0641	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
71335-0938	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride
71335-0471	Dicyclomine Hydrochloride	Dicyclomine Hydrochloride