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PROMETHAZINE HYDROCHLORIDE

ANDA

PROMETHAZINE HYDROCHLORIDE | A216446 | ANNORA PHARMA PRIVATE LTD

2 strengths0 unique patents0 unique exclusivities

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$2.04

per ea

Lowest NADAC/Unit

$2.01

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
31722004031PROMETHAZINE 12.5 MG SUPPOS	$2.04	EA	Generic	—	2026-06-17
31722004131PROMETHAZINE 25 MG SUPPOSITORY	$2.01	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain3 active DMFs5 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

ZYDUS LIFESCIENCES LTDPROMETHAZINE HYDROCHLORIDE USP

DMF 198402006

EMCURE PHARMACEUTICALS LTDPROMETHAZINE HYDROCHLORIDE USP

DMF 258062012

AREVA SYNTHETICS LLCPROMETHAZINE HYDROCHLORIDE USP

DMF 421762025

PHENCHEM INDUSTRIES LTDInactivePROMETHAZINE HYDROCHLORIDE

DMF 19741972

MAY AND BAKER LTDInactivePROMETHAZINE HYDROCHLORIDE

DMF 94051991

SIGMA ALDRICH IRELAND LTDInactivePROMETHAZINE HYDROCHLORIDE

DMF 118881996

WANBURY LTDInactivePROMETHAZINE HYDROCHLORIDE

DMF 181732005

IPCA LABORATORIES LTDInactivePROMETHAZINE HYDROCHLORIDE USP

DMF 272412013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

Sort:

#001 — 12.5MG

0 patents0 exclusivities▴

SUPPOSITORY;RECTAL | Approved: Nov 2, 2022

No patent or exclusivity listings for this strength.

#002 — 25MG

0 patents0 exclusivities▾

SUPPOSITORY;RECTAL | Approved: Nov 2, 2022