FDA.reportPublic FDA data

PROMETHAZINE HYDROCHLORIDE

Product NDC
62135-774
11-digit product format
621350774
Labeler code
62135
Product ID
62135-774_499ebc74-646b-4e6d-e063-6394a90ab998
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROMETHAZINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA040026
Marketing category
ANDA
Marketing start
1998-09-25
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
6.25 mg/5mL
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 HYDROCHLORIDE6.25 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR61ZEH7I1I
Rxcui992432

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
d51697af-7f97-0559-95d1-fe94f3f031d5Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62135-774-232025-09-30C16284748780-13b156c62-2545-fb37-e063-e6dba90a4e07PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
62135-774-242025-09-30C16284748780-13b156c62-2545-fb37-e063-e6dba90a4e07PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
62135-774-412025-09-30C16284748780-13b156c62-2545-fb37-e063-e6dba90a4e07PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
62135-774-472025-09-30C16284748780-13b156c62-2545-fb37-e063-e6dba90a4e07PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
62135-774-232025-07-29C16284748780-13b156c62-2545-fb37-e063-e6dba90a4e07PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
62135-774-242025-07-29C16284748780-13b156c62-2545-fb37-e063-e6dba90a4e07PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
62135-774-412025-07-29C16284748780-13b156c62-2545-fb37-e063-e6dba90a4e07PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
62135-774-472025-07-29C16284748780-13b156c62-2545-fb37-e063-e6dba90a4e07PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-774-05PROMETHAZINE HYDROCHLORIDE5 mL in 1 CUPSOLUTION54
62135-774-10PROMETHAZINE HYDROCHLORIDE10 mL in 1 CUPSOLUTION104
62135-774-23PROMETHAZINE HYDROCHLORIDE2 in 1 BOXSOLUTION24
62135-774-23PROMETHAZINE HYDROCHLORIDE10 in 1 TRAYSOLUTION104
62135-774-24PROMETHAZINE HYDROCHLORIDE10 in 1 TRAYSOLUTION104
62135-774-24PROMETHAZINE HYDROCHLORIDE2 in 1 BOXSOLUTION24
62135-774-41PROMETHAZINE HYDROCHLORIDE120 mL in 1 BOTTLESOLUTION1204
62135-774-47PROMETHAZINE HYDROCHLORIDE473 mL in 1 BOTTLESOLUTION4734

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-774-05ML - Milliliter62135-77450c92e2b-9e09-45ba-a355-e13a46e34cde12025-03-04
62135-774-10ML - Milliliter62135-77401f79f3d-79a8-4f33-bf9a-36051de1795f12025-03-04
62135-774-23ML - Milliliter62135-7748bb32fe0-a530-4cb1-afa4-46f41a5213e112025-03-04
62135-774-24ML - Milliliter62135-774ef63ecf3-8568-4690-83c8-d38e05ba8e3712025-03-04
62135-774-41ML - Milliliter62135-7747a928ca5-21f5-468b-9a56-b7cfce91b4ae12023-12-05
62135-774-47ML - Milliliter62135-77429586084-c3f6-49d2-9b13-b1ad57b6630a12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-774PROMETHAZINE HYDROCHLORIDE SOLUTION [CHARTWELL RX, LLC]2Current NDC, 8 package rows20250215_2ca17cd4-460e-4d54-8c53-a58a2b80e5cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992432promethazine HCl 6.25 MG in 5 mL Oral SolutionPSN2ca17cd4-460e-4d54-8c53-a58a2b80e5cb4
992432promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD2ca17cd4-460e-4d54-8c53-a58a2b80e5cb4
992432promethazine HCl 6.25 MG per 5 ML Oral SyrupSY2ca17cd4-460e-4d54-8c53-a58a2b80e5cb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-774-05621350774055 mL in 1 CUP5 mlHistorical
62135-774-106213507741010 mL in 1 CUP10 mlHistorical
62135-774-23621350774232 TRAY in 1 BOX (62135-774-23) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-774-10) 2 tray2025-02-10NoNoHistorical
62135-774-24621350774242 TRAY in 1 BOX (62135-774-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-774-05) 2 tray2025-02-10NoNoHistorical
62135-774-4162135077441120 mL in 1 BOTTLE (62135-774-41) 120 ml2023-11-27NoNoHistorical
62135-774-4762135077447473 mL in 1 BOTTLE (62135-774-47) 473 ml2023-11-27NoNoHistorical