FDA.reportPublic FDA data

Tramadol Hydrochloride and Acetaminophen

Product NDC
68788-7652
11-digit product format
687887652
Labeler code
68788
Product ID
68788-7652_2b13eed2-ae9d-4111-8ab9-c2455dc3cb03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride and acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA077858
Marketing category
ANDA
Marketing start
2020-02-28
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
Active strength
38 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7652-1EA - Each68788-76526d8a68ab-7b76-4e34-bbf3-6e2ed2aabea212020-06-05
68788-7652-2EA - Each68788-7652c2b571a1-b8c3-4491-aba3-eb28fdc27ebe12020-06-05
68788-7652-3EA - Each68788-765287cc5ee4-5b44-4f03-9266-46e22a5aed9c12020-06-05
68788-7652-4EA - Each68788-765246c41933-38a0-4dac-8231-5dcb60ea017c12020-06-05
68788-7652-5EA - Each68788-76522a992a72-0da0-4eaa-a8a5-3aac08f0387f12020-06-05
68788-7652-6EA - Each68788-765205784aad-be31-49e7-87b0-384fadfed9bb12020-06-05
68788-7652-8EA - Each68788-76524eccf152-b485-49fc-bdea-83b8a92bbc4b12020-06-05
68788-7652-9EA - Each68788-7652fc404436-c290-4067-a75d-19f293c5f19e12020-06-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7652-168788765201100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7652-1) 2020-02-280000-00-00NoNoCurrent
68788-7652-26878876520220 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7652-2) 2020-02-280000-00-00NoNoCurrent
68788-7652-36878876520330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7652-3) 2020-02-280000-00-00NoNoCurrent
68788-7652-46878876520440 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7652-4) 2020-02-280000-00-00NoNoCurrent
68788-7652-56878876520550 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7652-5) 2020-02-280000-00-00NoNoCurrent
68788-7652-66878876520660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7652-6) 2020-02-280000-00-00NoNoCurrent
68788-7652-868788765208120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7652-8) 2020-02-280000-00-00NoNoCurrent
68788-7652-96878876520990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7652-9) 2020-02-280000-00-00NoNoCurrent