FDA.reportPublic FDA data

Promethazine Hydrochloride and Codeine Phosphate

Product NDC
17856-0065
11-digit product format
178560065
Labeler code
17856
Product ID
17856-0065_36c12aae-7566-5b2d-e063-6294a90a0dd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride and Codeine Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA200386
Marketing category
ANDA
Marketing start
2018-03-12
Substance
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
Active strength
10; 6.25 mg/5mL; mg/5mL
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Promethazine Hydrochloride and Codeine Phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CODEINE PHOSPHATE10 mg/5mL
PROMETHAZINE HYDROCHLORIDE6.25 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGSL05Y1MN6, R61ZEH7I1I
Rxcui991486

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
e9576821-a971-5261-628e-82ad9e10acdbProduct name220150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product 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
17856-0065-12025-06-18C16284748780-1d6a99b39-ad2c-a426-e053-dadaa90af4c20065-PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCL and CODEINE PHOSPHATE oral solution, CV Initial U.S. Approval: 1952
17856-0065-12022-01-28C16284748780-1d6a99b39-ad2c-a426-e053-dadaa90af4c20065-PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION safely and effectively. See full prescribing information for PROMETHAZINE HCL AND CODEINE PHOSPHATE ORAL SOLUTION. PROMETHAZINE HCL and CODEINE PHOSPHATE oral solution, CV Initial U.S. Approval: 1952

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0065-1Promethazine Hydrochloride and Codeine Phosphate5 mL in 1 CUP, UNIT-DOSESOLUTION53
17856-0065-1Promethazine Hydrochloride and Codeine Phosphate72 in 1 BOX, UNIT-DOSESOLUTION723
17856-0065-2Promethazine Hydrochloride and Codeine Phosphate5 mL in 1 CUP, UNIT-DOSESOLUTION53
17856-0065-2Promethazine Hydrochloride and Codeine Phosphate1 in 1 BAGSOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0065PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORP.]1Current NDC, Legacy NDC, 4 package rows20200808_f8fb13e3-bc09-4004-a911-a38b6bbb0058.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991486codeine phosphate 10 MG / promethazine HCl 6.25 MG in 5 mL Oral SolutionPSNf8fb13e3-bc09-4004-a911-a38b6bbb00583
991486codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDf8fb13e3-bc09-4004-a911-a38b6bbb00583
991486codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral SyrupSYf8fb13e3-bc09-4004-a911-a38b6bbb00583

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17856-0065-11785600650172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0065-1) / 5 mL in 1 CUP, UNIT-DOSE2020-08-070000-00-00NoNoCurrent
17856-0065-2178560065021 CUP, UNIT-DOSE in 1 BAG (17856-0065-2) / 5 mL in 1 CUP, UNIT-DOSE2025-06-04NoNoHistorical