Hydrocodone Bitartrate and Acetaminophen

Product NDC: 66689-004
11-digit product format: 666890004
Labeler code: 66689
Product ID: 66689-004_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: 2019-06-24
Marketing end: 0000-00-00
Substance: HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength: 3 mg/5mL; mg/5mL
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#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66689-004-50	2024-01-30	C162847	48780-1	1030e365-0938-111a-e063-dadaa90a10e2	41ebe34d-567d-4fea-9fcb-c93e990a7861

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66689-004-01	ML - Milliliter	66689-004	79b7396f-260a-4e1d-9d68-02a01794f896	1	2019-07-02
66689-004-50	ML - Milliliter	66689-004	92fc535a-6059-4704-b960-52782791b152	1	2019-07-02

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NO70W886KK	HYDROCODONE BITARTRATE	34195-34-1	HYDROCODONE BITARTRATE
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
66689-004-50	66689000450	50 CUP, UNIT-DOSE in 1 CASE (66689-004-50) > 5 mL in 1 CUP, UNIT-DOSE (66689-004-01)	2019-06-24	0000-00-00	No	No	Current