Promethazine with Codeine

Product NDC
17856-0605
11-digit product format
178560605
Labeler code
17856
Product ID
17856-0605_239606dd-c461-4316-95df-08f4adf59beb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride and codeine phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA088875
Marketing category
ANDA
Marketing start
2019-09-10
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE
Active strength
6 mg/5mL; mg/5mL
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0605-1Promethazine with Codeine72 in 1 BOX, UNIT-DOSESOLUTION722
17856-0605-1Promethazine with Codeine5 mL in 1 CUP, UNIT-DOSESOLUTION52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0605PROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SOLUTION [ATLANTIC BIOLOGICALS CORP.]2Legacy NDC, 2 package rows20210126_ab0d0c01-34e8-4b78-b375-61e921f763de.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 SolutionPSNab0d0c01-34e8-4b78-b375-61e921f763de2
991486codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDab0d0c01-34e8-4b78-b375-61e921f763de2
991486codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral SyrupSYab0d0c01-34e8-4b78-b375-61e921f763de2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17856-0605-11785606050172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0605-1) > 5 mL in 1 CUP, UNIT-DOSE2021-01-250000-00-00NoNoCurrent