promethazine hydrochloride and codeine phosphate

Product NDC
70408-185
11-digit product format
704080185
Labeler code
70408
Product ID
70408-185_e78195f4-5ace-42b1-b42b-df1546e5b596
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride and codeine phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
Nostrum Laboratories, Inc.
Application
ANDA090180
Marketing category
ANDA
Marketing start
2010-03-17
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
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
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70408-185-31promethazine hydrochloride and codeine phosphate118 mL in 1 BOTTLESOLUTION1182
70408-185-34promethazine hydrochloride and codeine phosphate473 mL in 1 BOTTLESOLUTION4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70408-185-31ML - Milliliter70408-18550393f02-0da2-434d-bc42-e8360fc3c86412017-03-06
70408-185-34ML - Milliliter70408-185da64800d-4ecb-4bed-beef-c6e4013c84af12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70408-185PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SOLUTION [NOSTRUM LABORATORIES, INC.]2Legacy NDC, 2 package rows20181212_14f50f2c-ee0e-4345-b6c6-80bd50171772.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 SolutionPSN14f50f2c-ee0e-4345-b6c6-80bd501717722
991486codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD14f50f2c-ee0e-4345-b6c6-80bd501717722
991486codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral SyrupSY14f50f2c-ee0e-4345-b6c6-80bd501717722

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70408-185-3170408018531118 mL in 1 BOTTLE (70408-185-31) 118 ml2010-03-170000-00-00NoNoCurrent
70408-185-3470408018534473 mL in 1 BOTTLE (70408-185-34) 473 ml2010-03-170000-00-00NoNoCurrent