NDC codes

FDA NDC Directory
Product NDC (as listed)43063-046Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43063-0046Add 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 NDC11-digit (billing)PackageCopy
43063-046-0343063004603430630046033 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-03)Marketed from Dec 6, 2010
43063-046-0643063004606430630046066 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-06)Marketed from Dec 6, 2010
43063-046-12430630046124306300461212 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-12)Marketed from Dec 6, 2010
43063-046-15430630046154306300461515 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-15)Marketed from Dec 6, 2010
43063-046-19430630046194306300461919 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-19)Marketed from Dec 6, 2010
43063-046-24430630046244306300462424 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-24)Marketed from Dec 6, 2010

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 Hydrochloride
Generic name (nonproprietary)
chlordiazepoxide hydrochloride
Active ingredients
Chlordiazepoxide hydrochloride — 25 mg/1
Dosage form
Capsule
Route
Oral
Labeler
PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 084769
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Benzodiazepines (Chemical structure)
Identifiers
Product ID 43063-046_3edd1001-c580-bf18-e063-6394a90a3c31SPL ID 3edd1001-c580-bf18-e063-6394a90a3c31SPL set ID 3cbd7cee-c4d7-4c95-93d8-09428169b937RxCUI 905495UNII MFM6K1XWDK
Pharmacologic class
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

N443063004603 followed by a unit qualifier and the quantity

Package 43063-0046-03. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Chlordiazepoxide HCl capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of chlordiazepoxide HCl capsules in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43063-046

What is NDC 43063-046?
43063-046 is the product NDC for Chlordiazepoxide Hydrochloride, Chlordiazepoxide hydrochloride 25 mg/1 capsule, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Chlordiazepoxide Hydrochloride.
What is the active ingredient?
Chlordiazepoxide hydrochloride.
Who is the labeler?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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 Hydrochloride?
27 other product NDCs are listed under this name. See all Chlordiazepoxide Hydrochloride 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 Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Chlordiazepoxide HydrochlorideChlordiazepoxide hydrochloride 10 mg/1CapsuleOralCoupler LLC67046-090967046-0909-03
Chlordiazepoxide HydrochlorideChlordiazepoxide hydrochloride 25 mg/1CapsuleOralUnit Dose Solutions, Inc.87441-01587441-0015-01
Chlordiazepoxide HydrochlorideChlordiazepoxide hydrochloride 25 mg/1CapsuleOralCouper LLC67046-091067046-0910-03
Chlordiazepoxide HydrochlorideChlordiazepoxide hydrochloride 10 mg/1CapsuleOralSafecor Health, LLC48433-01948433-0019-20
Chlordiazepoxide HydrochlorideChlordiazepoxide hydrochloride 25 mg/1CapsuleOralSafecor Health, LLC48433-02048433-0020-20
Chlordiazepoxide HydrochlorideChlordiazepoxide hydrochloride 25 mg/1CapsuleOralAmerican Health Packaging60687-80760687-0807-01
Chlordiazepoxide HydrochlorideChlordiazepoxide hydrochloride 25 mg/1CapsuleOralMylan Institutional Inc.51079-14151079-0141-20
Chlordiazepoxide HydrochlorideChlordiazepoxide hydrochloride 10 mg/1CapsuleOralMylan Institutional Inc.51079-37551079-0375-20
Chlordiazepoxide HydrochlorideChlordiazepoxide hydrochloride 5 mg/1Capsule, Gelatin coatedOralEpic Pharma, LLC42806-56442806-0564-01
Chlordiazepoxide HydrochlorideChlordiazepoxide hydrochloride 10 mg/1Capsule, Gelatin coatedOralEpic Pharma, LLC42806-56542806-0565-01

All 28 Chlordiazepoxide Hydrochloride NDCs

Other NDCs under ANDA 084769

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

FDA NDC Directory listings under ANDA 084769
ProductStrengthForm · routeLabelerProduct NDC
Chlordiazepoxide HydrochlorideChlordiazepoxide hydrochloride 25 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0555-0159
Chlordiazepoxide HydrochlorideChlordiazepoxide hydrochloride 25 mg/1CapsuleOralSafecor Health, LLC48433-020
Chlordiazepoxide HydrochlorideChlordiazepoxide hydrochloride 25 mg/1CapsuleOralMylan Institutional Inc.51079-141
Chlordiazepoxide HydrochlorideChlordiazepoxide hydrochloride 25 mg/1CapsuleOralClinical Solutions Wholesale, LLC58118-1590
Chlordiazepoxide HydrochlorideChlordiazepoxide hydrochloride 25 mg/1CapsuleOralAmerican Health Packaging60687-807
Chlordiazepoxide HydrochlorideChlordiazepoxide hydrochloride 25 mg/1CapsuleOralCouper LLC67046-0910
Chlordiazepoxide HydrochlorideChlordiazepoxide hydrochloride 25 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-5171
Chlordiazepoxide HydrochlorideChlordiazepoxide hydrochloride 25 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-5256
Chlordiazepoxide HydrochlorideChlordiazepoxide hydrochloride 25 mg/1CapsuleOralREMEDYREPACK INC.70518-0015
Chlordiazepoxide HydrochlorideChlordiazepoxide hydrochloride 25 mg/1CapsuleOralREMEDYREPACK INC.70518-0157
Chlordiazepoxide HydrochlorideChlordiazepoxide hydrochloride 25 mg/1CapsuleOralUnit Dose Solutions, Inc.87441-015

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