FDA.reportPublic FDA data

PROMETHAZINE HYDROCHLORIDE

Product NDC
43063-874
11-digit product format
430630874
Labeler code
43063
Product ID
43063-874_526a6362-0f9a-d536-e063-6394a90a5fd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040712
Marketing category
ANDA
Marketing start
2006-07-31
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PROMETHAZINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROMETHAZINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR61ZEH7I1I
Rxcui992447

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
43063-874-01PROMETHAZINE HYDROCHLORIDE100 in 1 BOTTLE, PLASTICTABLET10034
43063-874-02PROMETHAZINE HYDROCHLORIDE2 in 1 BOTTLE, PLASTICTABLET234
43063-874-04PROMETHAZINE HYDROCHLORIDE4 in 1 BOTTLE, PLASTICTABLET434
43063-874-05PROMETHAZINE HYDROCHLORIDE5 in 1 BOTTLE, PLASTICTABLET534
43063-874-06PROMETHAZINE HYDROCHLORIDE6 in 1 BOTTLE, PLASTICTABLET634
43063-874-10PROMETHAZINE HYDROCHLORIDE10 in 1 BOTTLE, PLASTICTABLET1034
43063-874-12PROMETHAZINE HYDROCHLORIDE12 in 1 BOTTLE, PLASTICTABLET1234
43063-874-15PROMETHAZINE HYDROCHLORIDE15 in 1 BOTTLE, PLASTICTABLET1534
43063-874-20PROMETHAZINE HYDROCHLORIDE20 in 1 BOTTLE, PLASTICTABLET2034
43063-874-25PROMETHAZINE HYDROCHLORIDE25 in 1 BOTTLE, PLASTICTABLET2534
43063-874-30PROMETHAZINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET3034
43063-874-79PROMETHAZINE HYDROCHLORIDE1 in 1 BOTTLE, PLASTICTABLET134
43063-874-95PROMETHAZINE HYDROCHLORIDE1000 in 1 BOTTLE, PLASTICTABLET100034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-874-01EA - Each43063-874987e410a-73eb-4878-8db8-abdb52b9038112018-09-05
43063-874-02EA - Each43063-8747d505a64-5fd1-4e6e-8c5a-e29bb4bc104512020-01-03
43063-874-04EA - Each43063-8749d912075-9496-4d04-a4e2-dd02141fc40012018-09-05
43063-874-05EA - Each43063-8745812f12c-922c-4e13-ba2a-4e372fd1dcd112018-10-11
43063-874-06EA - Each43063-87487122666-e74a-435d-9dc5-6c0fe5ccb5ab12018-09-05
43063-874-10EA - Each43063-87444ee249f-83c9-44ac-ade5-79c02162293812018-09-05
43063-874-12EA - Each43063-874b5c901be-052b-4ab6-a28a-85c5dbb890af12018-09-05
43063-874-15EA - Each43063-874e4bc891e-79c6-4d06-9b6c-c3dbf0950a9912018-09-05
43063-874-20EA - Each43063-8749a80c3b7-89c4-40e4-8c10-fde797e24f6512019-01-24
43063-874-25EA - Each43063-874f289459a-6b10-447a-9ee0-797b652e49da12025-12-16
43063-874-30EA - Each43063-874c74c9303-d493-49b4-aa3d-0cd5115fafca12018-10-11
43063-874-79EA - Each43063-87460d51596-0f31-4c2e-bbf8-a166403fffc312020-01-03
43063-874-95EA - Each43063-874b4639846-acbd-4920-aa12-2ef8d386975b12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-874PROMETHAZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]31Current NDC, Legacy NDC, 13 package rows20250316_5ce082e9-13eb-4e63-a9e2-657d3ef0e9f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992447promethazine HCl 25 MG Oral TabletPSN5ce082e9-13eb-4e63-a9e2-657d3ef0e9f834
992447promethazine hydrochloride 25 MG Oral TabletSCD5ce082e9-13eb-4e63-a9e2-657d3ef0e9f834

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-874-0143063087401100 TABLET in 1 BOTTLE, PLASTIC (43063-874-01) 100 tablet2018-08-160000-00-00NoNoCurrent
43063-874-02430630874022 TABLET in 1 BOTTLE, PLASTIC (43063-874-02) 2 tablet2019-11-110000-00-00NoNoCurrent
43063-874-04430630874044 TABLET in 1 BOTTLE, PLASTIC (43063-874-04) 4 tablet2018-08-270000-00-00NoNoCurrent
43063-874-05430630874055 TABLET in 1 BOTTLE, PLASTIC (43063-874-05) 5 tablet2018-09-060000-00-00NoNoCurrent
43063-874-06430630874066 TABLET in 1 BOTTLE, PLASTIC (43063-874-06) 6 tablet2018-08-270000-00-00NoNoCurrent
43063-874-104306308741010 TABLET in 1 BOTTLE, PLASTIC (43063-874-10) 10 tablet2018-07-300000-00-00NoNoCurrent
43063-874-124306308741212 TABLET in 1 BOTTLE, PLASTIC (43063-874-12) 12 tablet2018-08-200000-00-00NoNoCurrent
43063-874-154306308741515 TABLET in 1 BOTTLE, PLASTIC (43063-874-15) 15 tablet2018-08-200000-00-00NoNoCurrent
43063-874-204306308742020 TABLET in 1 BOTTLE, PLASTIC (43063-874-20) 20 tablet2018-12-070000-00-00NoNoCurrent
43063-874-254306308742525 TABLET in 1 BOTTLE, PLASTIC (43063-874-25) 25 tablet2025-11-04NoNoCurrent
43063-874-304306308743030 TABLET in 1 BOTTLE, PLASTIC (43063-874-30) 30 tablet2018-09-050000-00-00NoNoCurrent
43063-874-79430630874791 TABLET in 1 BOTTLE, PLASTIC (43063-874-79) 1 tablet2019-11-070000-00-00NoNoCurrent
43063-874-95430630874951000 TABLET in 1 BOTTLE, PLASTIC (43063-874-95) 1000 tablet2018-08-170000-00-00NoNoCurrent