Tramadol Hydrochloride

Product NDC: 71610-865
11-digit product format: 716100865
Labeler code: 71610
Product ID: 71610-865_27460b14-190b-94e9-e063-6394a90ae97f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tramadol Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA075977
Marketing category: ANDA
Marketing start: 2002-06-19
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: 2026-12-31
Current FDA listing: Yes

Additional Listing Data

Finished product: Yes
Brand name base: Tramadol Hydrochloride
Listing expiration: 2026-12-31

Related Records

DailyMed label linked from SPL set ID

Active Ingredients

Ingredient	Strength
TRAMADOL HYDROCHLORIDE	50 mg/1

Harmonized Identifiers

Field	Values
Unii	9N7R477WCK
Rxcui	835603

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	Sample	Exclude flag	Status
71610-865-15	71610086515	15 TABLET, FILM COATED in 1 BOTTLE (71610-865-15)	2024-11-18	No	No	Historical
71610-865-20	71610086520	20 TABLET, FILM COATED in 1 BOTTLE (71610-865-20)	2024-11-18	No	No	Historical
71610-865-24	71610086524	224 TABLET, FILM COATED in 1 BOTTLE (71610-865-24)	2024-11-18	No	No	Historical
71610-865-28	71610086528	28 TABLET, FILM COATED in 1 BOTTLE (71610-865-28)	2024-11-18	No	No	Historical
71610-865-30	71610086530	30 TABLET, FILM COATED in 1 BOTTLE (71610-865-30)	2024-11-18	No	No	Historical
71610-865-40	71610086540	40 TABLET, FILM COATED in 1 BOTTLE (71610-865-40)	2024-11-18	No	No	Historical
71610-865-45	71610086545	45 TABLET, FILM COATED in 1 BOTTLE (71610-865-45)	2024-11-18	No	No	Historical
71610-865-46	71610086546	56 TABLET, FILM COATED in 1 BOTTLE (71610-865-46)	2024-11-18	No	No	Historical
71610-865-50	71610086550	50 TABLET, FILM COATED in 1 BOTTLE (71610-865-50)	2024-11-18	No	No	Historical
71610-865-53	71610086553	60 TABLET, FILM COATED in 1 BOTTLE (71610-865-53)	2024-11-18	No	No	Historical
71610-865-54	71610086554	84 TABLET, FILM COATED in 1 BOTTLE (71610-865-54)	2024-11-18	No	No	Historical
71610-865-57	71610086557	80 TABLET, FILM COATED in 1 BOTTLE (71610-865-57)	2024-11-18	No	No	Historical
71610-865-60	71610086560	90 TABLET, FILM COATED in 1 BOTTLE (71610-865-60)	2024-11-18	No	No	Historical
71610-865-65	71610086565	100 TABLET, FILM COATED in 1 BOTTLE (71610-865-65)	2024-11-18	No	No	Historical
71610-865-67	71610086567	168 TABLET, FILM COATED in 1 BOTTLE (71610-865-67)	2024-11-18	No	No	Historical
71610-865-70	71610086570	120 TABLET, FILM COATED in 1 BOTTLE (71610-865-70)	2024-11-18	No	No	Historical
71610-865-72	71610086572	112 TABLET, FILM COATED in 1 BOTTLE (71610-865-72)	2024-11-18	No	No	Historical
71610-865-73	71610086573	135 TABLET, FILM COATED in 1 BOTTLE (71610-865-73)	2024-11-18	No	No	Historical
71610-865-75	71610086575	150 TABLET, FILM COATED in 1 BOTTLE (71610-865-75)	2024-11-18	No	No	Historical
71610-865-80	71610086580	180 TABLET, FILM COATED in 1 BOTTLE (71610-865-80)	2024-11-18	No	No	Historical
71610-865-85	71610086585	200 TABLET, FILM COATED in 1 BOTTLE (71610-865-85)	2024-11-18	No	No	Historical
71610-865-90	71610086590	240 TABLET, FILM COATED in 1 BOTTLE (71610-865-90)	2024-11-18	No	No	Historical
71610-865-92	71610086592	270 TABLET, FILM COATED in 1 BOTTLE (71610-865-92)	2024-11-18	No	No	Historical

Related DailyMed Labels

Title	Manufacturer	Effective date	Type	Version
Tramadol Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2024-11-18	HUMAN PRESCRIPTION DRUG LABEL	1