NDC 52959-731

PROMETHEGAN

Promethazine Hydrochloride

PROMETHEGAN is a Rectal Suppository in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Promethazine Hydrochloride.

Product ID52959-731_a69a3507-3ae2-4226-86e6-3cc872ad2fdb
NDC52959-731
Product TypeHuman Prescription Drug
Proprietary NamePROMETHEGAN
Generic NamePromethazine Hydrochloride
Dosage FormSuppository
Route of AdministrationRECTAL
Marketing Start Date2002-02-28
Marketing CategoryANDA / ANDA
Application NumberANDA040428
Labeler NameH.J. Harkins Company, Inc.
Substance NamePROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesPhenothiazine [EPC],Phenothiazines [CS]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 52959-731-12

12 SUPPOSITORY in 1 BOX (52959-731-12)
Marketing Start Date2002-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-731-12 [52959073112]

PROMETHEGAN SUPPOSITORY
Marketing CategoryANDA
Application NumberANDA040428
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-02-28
Inactivation Date2020-01-31

NDC 52959-731-10 [52959073110]

PROMETHEGAN SUPPOSITORY
Marketing CategoryANDA
Application NumberANDA040428
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2002-02-28
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:80a7fabd-20c1-40fa-878e-7e62983dbc89
Manufacturer
UNII

Pharmacological Class

  • Phenothiazine [EPC]
  • Phenothiazines [CS]

NDC Crossover Matching brand name "PROMETHEGAN" or generic name "Promethazine Hydrochloride"

NDCBrand NameGeneric Name
0713-0132PROMETHEGANPROMETHEGAN
0713-0526PROMETHEGANPROMETHEGAN
0713-0536PROMETHEGANPROMETHEGAN
21695-959PrometheganPromethegan
50090-1575PROMETHEGANPROMETHEGAN
52959-731PROMETHEGANPROMETHEGAN
55289-928PROMETHEGANPROMETHEGAN
0591-2985PHENADOZPromethazine Hydrochloride
0591-2992PHENADOZPromethazine Hydrochloride
0641-6082PHENERGANPromethazine Hydrochloride
0641-6083PHENERGANPromethazine Hydrochloride
0641-6084PHENERGANPromethazine Hydrochloride
0615-1539PromethazinePromethazine Hydrochloride
0121-0927Promethazine HydrochloridePromethazine Hydrochloride
0404-9940PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE
0404-9941Promethazine HydrochloridePromethazine Hydrochloride
0404-9942Promethazine HydrochloridePromethazine Hydrochloride
0440-5195Promethazine HydrochloridePromethazine Hydrochloride
0440-8195Promethazine HydrochloridePromethazine Hydrochloride
0591-5307Promethazine HydrochloridePromethazine Hydrochloride
0591-5319Promethazine HydrochloridePromethazine Hydrochloride
0603-1584Promethazine HydrochloridePromethazine Hydrochloride
0615-7668promethazine hydrochloridepromethazine hydrochloride
0615-8154Promethazine HydrochloridePromethazine Hydrochloride
0641-0928Promethazine HydrochloridePromethazine Hydrochloride
0641-0929Promethazine HydrochloridePromethazine Hydrochloride
0641-0948Promethazine HydrochloridePromethazine Hydrochloride
0641-0949Promethazine HydrochloridePromethazine Hydrochloride
0641-0955Promethazine HydrochloridePromethazine Hydrochloride
0641-0956Promethazine HydrochloridePromethazine Hydrochloride
0641-1495Promethazine HydrochloridePromethazine Hydrochloride
0641-1496Promethazine HydrochloridePromethazine Hydrochloride

Trademark Results [PROMETHEGAN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROMETHEGAN
PROMETHEGAN
97461296 not registered Live/Pending
Cosette Pharmaceuticals, Inc.
2022-06-16
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