FDA.reportPublic FDA data

PROMETHEGAN

Product NDC
0713-0526
11-digit product format
007130526
Labeler code
0713
Product ID
0713-0526_0b622b7b-a45f-eab0-e063-6394a90a0c0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA040428
Marketing category
ANDA
Marketing start
2002-02-28
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PROMETHEGAN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROMETHAZINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR61ZEH7I1I
Rxcui992441, 992445, 992454, 992459

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
d51697af-7f97-0559-95d1-fe94f3f031d5Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0713-0526-10PROMETHEGAN1000 in 1 BOXSUPPOSITORY10007
0713-0526-12PROMETHEGAN12 in 1 BOXSUPPOSITORY127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0526-10EA - Each0713-05265ef6ffcb-e3bf-4c7c-b966-2667e8f2f1fe12013-02-13
0713-0526-12EA - Each0713-052623dea9ff-b271-4a2d-a5bd-39e161d1173c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Promethazine HydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.]2
Promethazine HydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [H.J. HARKINS COMPANY, INC.]2
PromethazineACTIVE MOIETYFF28EJQ494PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [H.J. HARKINS COMPANY, INC.]2
PromethazineACTIVE MOIETYFF28EJQ494PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.]2
Ascorbyl PalmitateINACTIVE INGREDIENTQN83US2B0NPROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.]2
Ascorbyl PalmitateINACTIVE INGREDIENTQN83US2B0NPROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [H.J. HARKINS COMPANY, INC.]2
Fat, HardINACTIVE INGREDIENT8334LX7S21PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.]2
Fat, HardINACTIVE INGREDIENT8334LX7S21PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [H.J. HARKINS COMPANY, INC.]2
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [H.J. HARKINS COMPANY, INC.]2
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [H.J. HARKINS COMPANY, INC.]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.]2
White WaxINACTIVE INGREDIENT7G1J5DA97FPROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [H.J. HARKINS COMPANY, INC.]2
White WaxINACTIVE INGREDIENT7G1J5DA97FPROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [G&W LABORATORIES, INC.]2
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [REBEL DISTRIBUTORS CORP]1
Promethazine HydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]1
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [REBEL DISTRIBUTORS CORP]1
PromethazineACTIVE MOIETYFF28EJQ494PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]1
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NPROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [REBEL DISTRIBUTORS CORP]1
Ascorbyl PalmitateINACTIVE INGREDIENTQN83US2B0NPROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]1
Fat, HardINACTIVE INGREDIENT8334LX7S21PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]1
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [REBEL DISTRIBUTORS CORP]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]1
White WaxINACTIVE INGREDIENT7G1J5DA97FPROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0526PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [COSETTE PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 2 package rows20231201_5f079815-f48b-8b21-2130-7f791d967c9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992441promethazine HCl 12.5 MG Rectal SuppositoryPSN5f079815-f48b-8b21-2130-7f791d967c9a7
992454promethazine HCl 25 MG Rectal SuppositoryPSN5f079815-f48b-8b21-2130-7f791d967c9a7
992445PROMETHEGAN 12.5 MG Rectal SuppositoryPSN5f079815-f48b-8b21-2130-7f791d967c9a7
992459PROMETHEGAN 25 MG Rectal SuppositoryPSN5f079815-f48b-8b21-2130-7f791d967c9a7
992445promethazine hydrochloride 12.5 MG Rectal Suppository [Promethegan]SBD5f079815-f48b-8b21-2130-7f791d967c9a7
992459promethazine hydrochloride 25 MG Rectal Suppository [Promethegan]SBD5f079815-f48b-8b21-2130-7f791d967c9a7
992441promethazine hydrochloride 12.5 MG Rectal SuppositorySCD5f079815-f48b-8b21-2130-7f791d967c9a7
992454promethazine hydrochloride 25 MG Rectal SuppositorySCD5f079815-f48b-8b21-2130-7f791d967c9a7
992445Promethegan 12.5 MG Rectal SuppositorySY5f079815-f48b-8b21-2130-7f791d967c9a7
992459Promethegan 25 MG Rectal SuppositorySY5f079815-f48b-8b21-2130-7f791d967c9a7
992454promethazine HCl 25 MG Rectal SuppositoryPSNc809171c-d424-4a17-a98d-f280a892b4101
992459PROMETHEGAN 25 MG Rectal SuppositoryPSNc809171c-d424-4a17-a98d-f280a892b4101
992459promethazine hydrochloride 25 MG Rectal Suppository [Promethegan]SBDc809171c-d424-4a17-a98d-f280a892b4101
992454promethazine hydrochloride 25 MG Rectal SuppositorySCDc809171c-d424-4a17-a98d-f280a892b4101
992459Promethegan 25 MG Rectal SuppositorySYc809171c-d424-4a17-a98d-f280a892b4101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0526-10007130526101000 SUPPOSITORY in 1 BOX (0713-0526-10) 1000 suppository2002-02-280000-00-00NoNoCurrent
0713-0526-120071305261212 SUPPOSITORY in 1 BOX (0713-0526-12) 12 suppository2002-02-280000-00-00NoNoCurrent