NDC 60429-583

Tramadol Hydrochloride Extended-Release

Tramadol Hydrochloride Extended-release Tablets

Tramadol Hydrochloride Extended-Release is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Golden State Medical Supply, Inc.. The primary component is Tramadol Hydrochloride.

• Product ID: 60429-583_7acc981e-0bff-1a70-e053-2991aa0a648b
• NDC: 60429-583
• Product Type: Human Prescription Drug
• Proprietary Name: Tramadol Hydrochloride Extended-Release
• Generic Name: Tramadol Hydrochloride Extended-release Tablets
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2016-10-20
• Marketing Category: ANDA / ANDA
• Application Number: ANDA200491
• Labeler Name: Golden State Medical Supply, Inc.
• Substance Name: TRAMADOL HYDROCHLORIDE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 60429-583-30

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60429-583-30)

• Marketing Start Date: 2016-10-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 60429-583-30 [60429058330]

Tramadol Hydrochloride Extended-Release TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA200491
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-10-20

Drug Details

Active Ingredients

Ingredient	Strength
TRAMADOL HYDROCHLORIDE	100 mg/1

OpenFDA Data

• SPL SET ID: 7388d49b-d1b2-4cbb-9bde-50dbbdd78889
• Manufacturer:
  • Golden State Medical Supply, Inc.
• UNII:
  • 9N7R477WCK
• RxNorm Concept Unique ID - RxCUI:
  • 1946529
  • 1946525
  • 1946527

Pharmacological Class

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]

NDC Crossover Matching brand name "Tramadol Hydrochloride Extended-Release" or generic name "Tramadol Hydrochloride Extended-release Tablets"

NDC	Brand Name	Generic Name
13811-691	Tramadol Hydrochloride Extended-Release	Tramadol Hydrochloride Extended-Release
13811-690	Tramadol Hydrochloride Extended-Release	Tramadol Hydrochloride Extended-Release
13811-689	Tramadol Hydrochloride Extended-Release	Tramadol Hydrochloride Extended-Release
60429-583	Tramadol Hydrochloride	tramadol hydrochloride extended-release tablets
60429-584	Tramadol Hydrochloride	Tramadol Hydrochloride Extended-Release Tablets
60429-585	Tramadol Hydrochloride	Tramadol Hydrochloride Extended-Release Tablets