FDA.reportPublic FDA data

DODEX INJECTABLE

Product NDC
16729-533
11-digit product format
167290533
Labeler code
16729
Product ID
16729-533_e8770836-7fda-e833-e053-2995a90a1d39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyanocobalamin
Dosage form
INJECTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Accord Healthcare, Inc.
Application
ANDA083022
Marketing category
ANDA
Marketing start
2022-04-29
Marketing end
0000-00-00
Substance
CYANOCOBALAMIN
Active strength
1000 ug/mL
Pharmacologic classes
Vitamin B 12 [CS], Vitamin B12 [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-533-03ML - Milliliter16729-53332dc306f-1aeb-4536-8cf5-1953fa49a06c12022-05-04
16729-533-08ML - Milliliter16729-533894fdca8-11aa-416b-b90f-385ad8507f9c12022-05-04
16729-533-10ML - Milliliter16729-533bc1c815a-ae64-466f-86ff-311193f58cf812022-05-04
16729-533-63ML - Milliliter16729-533d929f137-e838-4bd5-b7f0-c03aeedcabfb12023-01-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-533-081672905330825 VIAL, MULTI-DOSE in 1 BOX (16729-533-08) > 1 mL in 1 VIAL, MULTI-DOSE2022-04-100000-00-00NoNoCurrent