tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: cranbury pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler cranbury pharmaceuticals, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tramadol hydrochloride 50 mg/1

Manufacturer
Cranbury Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 27808-301
Product ID 27808-301_18541c83-30aa-4df4-9d72-915629ee01f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091498
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2024-12-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27808301
Hyphenated Format 27808-301

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 ANDA091498 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (27808-301-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (27808-301-02)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (27808-301-03)
source: ndc

Packages (3)

27808-301-01 100 TABLET, FILM COATED in 1 BOTTLE (27808-301-01) 27808-301-02 500 TABLET, FILM COATED in 1 BOTTLE (27808-301-02) 27808-301-03 1000 TABLET, FILM COATED in 1 BOTTLE (27808-301-03)

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": "18541c83-30aa-4df4-9d72-915629ee01f9", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["835603"], "spl_set_id": ["1d4af58f-17f3-4cbd-870c-098ace954872"], "manufacturer_name": ["Cranbury Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (27808-301-01)", "package_ndc": "27808-301-01", "marketing_start_date": "20241222"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (27808-301-02)", "package_ndc": "27808-301-02", "marketing_start_date": "20241222"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (27808-301-03)", "package_ndc": "27808-301-03", "marketing_start_date": "20241222"}], "brand_name": "TRAMADOL HYDROCHLORIDE", "product_id": "27808-301_18541c83-30aa-4df4-9d72-915629ee01f9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "27808-301", "dea_schedule": "CIV", "generic_name": "TRAMADOL HYDROCHLORIDE", "labeler_name": "Cranbury Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TRAMADOL HYDROCHLORIDE", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA091498", "marketing_category": "ANDA", "marketing_start_date": "20241222", "listing_expiration_date": "20261231"}