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FDA Product

pentazocine and naloxone

Product approved by U.S. Food and Drug Administration (US)

Basic Information

pentazocine and naloxone

63304-506

Regulatory Information

63304-506

ANDA075523

C73584

July 31, 2018

USA

PENTAZOCINE AND NALOXONE HYDROCHLORIDE TABLETS USP Analgesic for Oral Use Only Rx only

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

146974886

Active Ingredients

PENTAZOCINE

Quantity: 50 mg in 1 1

Code: RP4A60D26L

Class Code: ACTIB

NALOXONE HYDROCHLORIDE

Quantity: 0.5 mg in 1 1

Code: F850569PQR

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATE

Code: L11K75P92J

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

ALUMINUM OXIDE

Code: LMI26O6933

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

Active Moieties

NALOXONE

Code: 36B82AMQ7N

PENTAZOCINE

Code: RP4A60D26L

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