NDC 33342-462 Cycloserine


NDC Product Code 33342-462

NDC Code: 33342-462

Proprietary Name: Cycloserine Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Cycloserine Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics
Shape: CAPSULE (C48336)
19 MM
Score: 1

Code Structure
  • 33342 - Macleods Pharmaceuticals Limited
    • 33342-462 - Cycloserine

NDC 33342-462-06

Package Description: 3 BLISTER PACK in 1 CARTON > 10 CAPSULE in 1 BLISTER PACK (33342-462-66)

NDC Product Information

Cycloserine with NDC 33342-462 is a a human prescription drug product labeled by Macleods Pharmaceuticals Limited. The generic name of Cycloserine is cycloserine. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Macleods Pharmaceuticals Limited

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

Product Type: Human Prescription Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Cycloserine Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CYCLOSERINE 250 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • GELATIN (UNII: 2G86QN327L)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

* Please review the disclaimer below.

Cycloserine Product Label Images

Cycloserine Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Health Care Provider Letter Section

Subject: Temporary importation of cycloSERINE, 250 mg capsules to address shortageJanuary 07, 2019Dear Healthcare Professional,Due to an anticipated shortage of SEROMYCIN® - cycloSERINE capsules, 250mg in the United States (U.S.) market by the end of 2018, Macleods Pharmaceuticals Limited, India (Macleods) is co-ordinating with the U.S. Food and Drug Administration (FDA) to increase the availability of cycloSERINE capsules, 250mg for patients in the United States. Macleods has initiated temporary importation of cycloSERINE capsules, 250 mg into the United States market. This drug product is marketed globally and is manufactured in India.At this time no other entity except Macleods is authorized by the FDA to import cycloSERINE capsules, 250 mg in the United States. FDA has not approved Macleods cycloSERINE capsules, 250 mg in the United States. Effective immediately, and during this temporary period, Macleods will offer the following version:Product Name and DescriptionQuantity/PackagingNDCcycloSERINE Capsules, 250mg30 Capsules, Non-Child ResistantPacks of 3x10NDC 33342-462-06 It is important to note the following: • The imported product and U.S. FDA-approved product (SEROMYCIN®) contain the same active ingredient (cycloSERINE), strength (250 mg), and dosage form (capsules).  • Please note the difference in the imported capsules’ appearance.  The imported cycloSERINE capsule is maroon-colored.  The U.S.FDA-approved SEROMYCIN® (cycloSERINE) capsule has an opaque red cap and opaque grey body and is imprinted with “CHAO” and “F04”. U.S. FDA Approved ProductImported ProductSeromycin (cycloSERINE) capsule, 250 mgcycloSERINE capsule, 250 mg • The barcode may not register accurately on the U.S. scanning systems.  Alternative procedures should be followed to assure that the correct drug product is being used and administered to individual patients.  For example, institutions should consider manually inputting the product into their systems and confirm that barcode systems do no provide incorrect information when the product is scanned.  Please refer to the package insert for the FDA-approved cycloSERINE capsules for full prescribing information, including the Warning section for risk of CNS toxicity.The product comparison table below highlights the differences between the FDA-approved SEROMYCIN (cycloSERINE) capsules and the imported cycloSERINE capsules.To place an order, or if you have any questions about the information contained in this letter or the use of cycloSERINE capsules, 250 mg, please contact Macleods at 1-888-943-3210 between the hours of 8 a.m. and 5 p.m. (ET), or email at safety@macleodspharma.com.To report adverse events or quality problems associated with the use of this product, please call Macleods at 1-888-943-3210 between the hours of 8 a.m. and 5 p.m. (ET), or email at safety@macleodspharma.com.Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.• Complete and submit the report Online: www.fda.gov/medwatch/report.htm • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htmor call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (1-800-332-0178)We urge you to contact our Medical Information Department at 1-888-943-3210 between the hours of 8 a.m. and 5 p.m. (ET), or email safety@macleodspharma.com. If you have any questions about the information contained in this letter or the safe and effective use of CycloSERINE capsules.Sincerely,Dr Ashish Mungatiwar Executive President Medical Services Macleods Pharmaceuticals Comparison Table

* Please review the disclaimer below.

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