tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler rising pharma holdings, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tramadol hydrochloride 50 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-716
Product ID 16571-716_0803af00-9ccd-46e7-b1f6-571ce6674049
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203494
DEA Schedule civ
Listing Expiration 2027-12-31
Marketing Start 2020-09-23

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571716
Hyphenated Format 16571-716

Supplemental Identifiers

RxCUI
835603
UNII
9N7R477WCK

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tramadol hydrochloride (source: ndc)
Generic Name tramadol hydrochloride (source: ndc)
Application Number ANDA203494 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (16571-716-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (16571-716-10)
  • 500 TABLET, FILM COATED in 1 BOTTLE (16571-716-50)
source: ndc

Packages (3)

16571-716-01 100 TABLET, FILM COATED in 1 BOTTLE (16571-716-01) 16571-716-10 1000 TABLET, FILM COATED in 1 BOTTLE (16571-716-10) 16571-716-50 500 TABLET, FILM COATED in 1 BOTTLE (16571-716-50)

Ingredients (1)

tramadol hydrochloride (50 mg/1)

Linked Drug Pages (1)

Tramadol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0803af00-9ccd-46e7-b1f6-571ce6674049", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["835603"], "spl_set_id": ["a63eadda-cabb-4f2c-86f9-2d8b4a2c88f3"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (16571-716-01)", "package_ndc": "16571-716-01", "marketing_start_date": "20200923"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (16571-716-10)", "package_ndc": "16571-716-10", "marketing_start_date": "20200923"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (16571-716-50)", "package_ndc": "16571-716-50", "marketing_start_date": "20200923"}], "brand_name": "Tramadol Hydrochloride", "product_id": "16571-716_0803af00-9ccd-46e7-b1f6-571ce6674049", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "16571-716", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tramadol Hydrochloride", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA203494", "marketing_category": "ANDA", "marketing_start_date": "20200923", "listing_expiration_date": "20271231"}