Tramadol Hydrochloride

Product NDC: 71610-392
11-digit product format: 716100392
Labeler code: 71610
Product ID: 71610-392_9298ddb2-c8eb-4c15-aef0-a938e0975a3a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tramadol Hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA076003
Marketing category: ANDA
Marketing start: 2010-11-15
Marketing end: 0000-00-00
Substance: TRAMADOL HYDROCHLORIDE
Active strength: 50 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

Related Records

Related UNII Ingredients

UNII	Preferred term	Registry number	Matched term
9N7R477WCK	TRAMADOL HYDROCHLORIDE	36282-47-0	TRAMADOL HYDROCHLORIDE

Packages

Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-392-15	71610039215	15 TABLET, COATED in 1 BOTTLE (71610-392-15)	2020-01-28	0000-00-00	No	No	Current
71610-392-20	71610039220	20 TABLET, COATED in 1 BOTTLE (71610-392-20)	2020-01-28	0000-00-00	No	No	Current
71610-392-24	71610039224	224 TABLET, COATED in 1 BOTTLE (71610-392-24)	2020-01-28	0000-00-00	No	No	Current
71610-392-28	71610039228	28 TABLET, COATED in 1 BOTTLE (71610-392-28)	2020-01-28	0000-00-00	No	No	Current
71610-392-30	71610039230	30 TABLET, COATED in 1 BOTTLE (71610-392-30)	2020-01-28	0000-00-00	No	No	Current
71610-392-40	71610039240	40 TABLET, COATED in 1 BOTTLE (71610-392-40)	2020-01-28	0000-00-00	No	No	Current
71610-392-45	71610039245	45 TABLET, COATED in 1 BOTTLE (71610-392-45)	2020-01-28	0000-00-00	No	No	Current
71610-392-46	71610039246	56 TABLET, COATED in 1 BOTTLE (71610-392-46)	2020-01-28	0000-00-00	No	No	Current
71610-392-50	71610039250	50 TABLET, COATED in 1 BOTTLE (71610-392-50)	2020-01-28	0000-00-00	No	No	Current
71610-392-53	71610039253	60 TABLET, COATED in 1 BOTTLE (71610-392-53)	2020-01-28	0000-00-00	No	No	Current
71610-392-54	71610039254	84 TABLET, COATED in 1 BOTTLE (71610-392-54)	2020-01-28	0000-00-00	No	No	Current
71610-392-57	71610039257	80 TABLET, COATED in 1 BOTTLE (71610-392-57)	2020-01-28	0000-00-00	No	No	Current
71610-392-60	71610039260	90 TABLET, COATED in 1 BOTTLE (71610-392-60)	2020-01-28	0000-00-00	No	No	Current
71610-392-65	71610039265	100 TABLET, COATED in 1 BOTTLE (71610-392-65)	2020-01-28	0000-00-00	No	No	Current
71610-392-67	71610039267	168 TABLET, COATED in 1 BOTTLE (71610-392-67)	2020-01-28	0000-00-00	No	No	Current
71610-392-70	71610039270	120 TABLET, COATED in 1 BOTTLE (71610-392-70)	2020-01-28	0000-00-00	No	No	Current
71610-392-72	71610039272	112 TABLET, COATED in 1 BOTTLE (71610-392-72)	2020-01-28	0000-00-00	No	No	Current
71610-392-73	71610039273	135 TABLET, COATED in 1 BOTTLE (71610-392-73)	2020-01-28	0000-00-00	No	No	Current
71610-392-75	71610039275	150 TABLET, COATED in 1 BOTTLE (71610-392-75)	2020-01-28	0000-00-00	No	No	Current
71610-392-80	71610039280	180 TABLET, COATED in 1 BOTTLE (71610-392-80)	2020-01-28	0000-00-00	No	No	Current
71610-392-85	71610039285	200 TABLET, COATED in 1 BOTTLE (71610-392-85)	2020-01-28	0000-00-00	No	No	Current
71610-392-90	71610039290	240 TABLET, COATED in 1 BOTTLE (71610-392-90)	2020-01-28	0000-00-00	No	No	Current
71610-392-94	71610039294	360 TABLET, COATED in 1 BOTTLE (71610-392-94)	2020-01-30	0000-00-00	No	No	Current

Related DailyMed Labels

Title	Manufacturer	Effective date	Type	Version
Tramadol Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2020-02-19	HUMAN PRESCRIPTION DRUG LABEL	1