Hydrocodone Bitartrate and Acetaminophen

Product NDC
66689-023
11-digit product format
666890023
Labeler code
66689
Product ID
66689-023_e297e7d7-cf6b-4bbd-9f87-5dfcfebe36e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
SOLUTION
Route
ORAL
Labeler
VistaPharm, Inc.
Application
ANDA200343
Marketing category
ANDA
Marketing start
2017-01-05
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
8 mg/15mL; mg/15mL
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-023-01ML - Milliliter66689-023d83a356b-b41a-47b7-b9ef-d356f95cd20212012-07-24
66689-023-04ML - Milliliter66689-0237365ec33-17e9-4d9e-8743-cdf31cdcbfea12013-12-02
66689-023-16ML - Milliliter66689-023db01aedf-1c0f-43ea-8530-9be1cb4c5a9712012-07-24
66689-023-50ML - Milliliter66689-02378431ad9-698d-4cec-9d1d-cc30e984fc8712012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66689-023-0466689002304120 mL in 1 BOTTLE (66689-023-04) 120 ml2017-01-050000-00-00NoNoCurrent
66689-023-1666689002316473 mL in 1 BOTTLE (66689-023-16) 473 ml2017-01-050000-00-00NoNoCurrent
66689-023-506668900235050 CUP, UNIT-DOSE in 1 CASE (66689-023-50) > 15 mL in 1 CUP, UNIT-DOSE (66689-023-01) 2017-01-050000-00-00NoNoCurrent