Sterile Diluent Injection
NDC Package 0006-4309-00

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Sterile Diluent (sterile water) injection is hypersensitivity to any component of the vaccine, including gelatin.{40}Do not give M-M-R II to pregnant females; the possible effects of the vaccine on fetal development are unknown at this time. This formulation utilizes a injection delivery system. Marketed by Merck Sharp & Dohme Llc, this product is identified by NDC 0006-4309 and is authorized under FDA application BLA125123.

Identification & Billing

NDC Package Code
0006-4309-00
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / .7 mL in 1 VIAL, SINGLE-DOSE (0006-4309-01)
Product Code
0006-4309
11-Digit Billing Format
00006430900
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 804183 - measles, mumps, and rubella virus vaccine live (generic for M-M-R II) 0.5 ML Injection
  • RxCUI: 804183 - 0.5 ML measles virus vaccine live, Enders' attenuated Edmonston strain 2000 UNT/ML / mumps virus vaccine live, Jeryl Lynn strain 25000 UNT/ML / rubella virus vaccine live (Wistar RA 27-3 strain) 2000 UNT/ML Injection
  • RxCUI: 804186 - M-M-R II vaccine 0.5 ML Injection
  • RxCUI: 804186 - 0.5 ML measles virus vaccine live, Enders' attenuated Edmonston strain 2000 UNT/ML / mumps virus vaccine live, Jeryl Lynn strain 25000 UNT/ML / rubella virus vaccine live (Wistar RA 27-3 strain) 2000 UNT/ML Injection [M-M-R II]
  • RxCUI: 804186 - M-M-R II, Measles, Mumps, and Rubella Virus Vaccine Live 0.5 ML Injection

Clinical Specifications

Proprietary Name
Sterile Diluent
Non-Proprietary Name
Sterile Water
Substance Name
Water
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
WATER .7 mL/.7mL
Usage Information
Hypersensitivity to any component of the vaccine, including gelatin.{40}Do not give M-M-R II to pregnant females; the possible effects of the vaccine on fetal development are unknown at this time. If vaccination of postpubertal females is undertaken, pregnancy should be avoided for three months following vaccination (see INDICATIONS AND USAGE, Non-Pregnant Adolescent and Adult Females and PRECAUTIONS, Pregnancy).Anaphylactic or anaphylactoid reactions to neomycin (each dose of reconstituted vaccine contains approximately 25 mcg of neomycin).Febrile respiratory illness or other active febrile infection. However, the ACIP has recommended that all vaccines can be administered to persons with minor illnesses such as diarrhea, mild upper respiratory infection with or without low-grade fever, or other low-grade febrile illness.{41}Patients receiving immunosuppressive therapy. This contraindication does not apply to patients who are receiving corticosteroids as replacement therapy, e.g., for Addison's disease.Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.Primary and acquired immunodeficiency states, including patients who are immunosuppressed in association with AIDS or other clinical manifestations of infection with human immunodeficiency viruses;{41-43} cellular immune deficiencies; and hypogammaglobulinemic and dysgammaglobulinemic states. Measles inclusion body encephalitis{44} (MIBE), pneumonitis{45} and death as a direct consequence of disseminated measles vaccine virus infection have been reported in immunocompromised individuals inadvertently vaccinated with measles-containing vaccine. Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.

Regulatory & Marketing

Labeler Name
Merck Sharp & Dohme Llc
Product Type
Vaccine
FDA Application #
BLA125123
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-25-2006
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0006-4309-00 identifies a specific commercial package of 10 vial, single-dose in 1 carton / .7 ml in 1 vial, single-dose (0006-4309-01) of Sterile Diluent, a vaccine label labeled by Merck Sharp & Dohme Llc. This injection is formulated for intramuscular; subcutaneous use and contains water as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Merck Sharp & Dohme Llc on May 25, 2006. The current certification is valid through December 31, 2026.

How is this Merck Sharp & Dohme Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00006430900. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0006-4309-00
11-Digit CMS (5-4-2)
00006-4309-00

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.