What is NDC 42571-381?

42571-381 is the product NDC for Chlordiazepoxide HCl And Clidinium Bromide, Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1 capsule, listed with the FDA by Micro Labs Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Chlordiazepoxide hydrochloride, Clidinium bromide.

Micro Labs Limited, NDC labeler code 42571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Chlordiazepoxide HCl And Clidinium Bromide?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Chlordiazepoxide HCl And Clidinium Bromide NDC 42571-381

NDC codes

FDA NDC Directory

Product NDC (as listed)42571-381Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42571-0381Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
42571-381-01	42571038101	100 CAPSULE in 1 BOTTLE (42571-381-01)Marketed from Oct 1, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Chlordiazepoxide HCl And Clidinium Bromide
Generic name (nonproprietary): chlordiazepoxide hcl and clidinium bromide
Active ingredients: Chlordiazepoxide hydrochloride — 5 mg/1Clidinium bromide — 2.5 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Micro Labs LimitedNDC labeler code 42571
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215835
Marketing start: Oct 1, 2022
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)Cholinergic Antagonists (Mechanism)Decreased Parasympathetic Acetylcholine Activity (Physiologic effect)Digestive/GI System Activity Alteration (Physiologic effect)GI Motility Alteration (Physiologic effect)
Identifiers: Product ID 42571-381_fa3753a6-a410-6ae8-e053-6394a90a0106SPL ID fa3753a6-a410-6ae8-e053-6394a90a0106SPL set ID cd820fcb-b6a8-43f4-a6d9-f94546d380c8RxCUI 889614UNII MFM6K1XWDK, 91ZQW5JF1ZUPC 0342571381011
Pharmacologic class: Anticholinergic; Benzodiazepine

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N442571038101 followed by a unit qualifier and the quantity

Package 42571-0381-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Apr 26, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Chlordiazepoxide hydrochloride and clidinium bromide capsule is indicated to control emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide hydrochloride and clidinium bromide capsules may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42571-381

What is NDC 42571-381?: 42571-381 is the product NDC for Chlordiazepoxide HCl And Clidinium Bromide, Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1 capsule, listed with the FDA by Micro Labs Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Chlordiazepoxide HCl And Clidinium Bromide.
What is the active ingredient?: Chlordiazepoxide hydrochloride, Clidinium bromide.
Who is the labeler?: Micro Labs Limited, NDC labeler code 42571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Chlordiazepoxide HCl And Clidinium Bromide?: 1 other product NDC are listed under this name. See all Chlordiazepoxide HCl And Clidinium Bromide NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Chlordiazepoxide HCl And Clidinium Bromide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Chlordiazepoxide HCl And Clidinium Bromide	Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2436	72162-2436-01

Other NDCs under ANDA 215835

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 215835
Product	Strength	Form · route	Labeler	Product NDC
Chlordiazepoxide HCl And Clidinium Bromide	Chlordiazepoxide hydrochloride 5 mg/1; Clidinium bromide 2.5 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2436