ACETAMINOPHEN AND CODEINE PHOSPHATE

Product NDC
63187-106
11-digit product format
631870106
Labeler code
63187
Product ID
63187-106_cd9e5061-9ddb-4d4b-a9d2-6509ea2c1e57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040419
Marketing category
ANDA
Marketing start
2011-07-06
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
300; 30 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ACETAMINOPHEN AND CODEINE PHOSPHATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN300 mg/1
CODEINE PHOSPHATE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, GSL05Y1MN6
Rxcui993781

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
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
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-106-15ACETAMINOPHEN AND CODEINE PHOSPHATE15 in 1 BOTTLETABLET159
63187-106-20ACETAMINOPHEN AND CODEINE PHOSPHATE20 in 1 BOTTLETABLET209
63187-106-30ACETAMINOPHEN AND CODEINE PHOSPHATE30 in 1 BOTTLETABLET309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-106-15EA - Each63187-1068ebfc1c6-d4c8-4c31-bb45-0ec6e1acf6a512022-05-04
63187-106-30EA - Each63187-106db164f03-4f57-46ba-977b-bfd8a9a76b3f12023-08-08

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-106ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PROFICIENT RX LP]9Current NDC, Legacy NDC, 3 package rows20240713_a8f8bb34-6d61-47a8-b58b-0b6763458052.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSNa8f8bb34-6d61-47a8-b58b-0b67634580529
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCDa8f8bb34-6d61-47a8-b58b-0b67634580529
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSYa8f8bb34-6d61-47a8-b58b-0b67634580529

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-106-156318701061515 TABLET in 1 BOTTLE (63187-106-15) 15 tablet2021-12-030000-00-00NoNoCurrent
63187-106-206318701062020 TABLET in 1 BOTTLE (63187-106-20) 20 tablet2019-01-010000-00-00NoNoCurrent
63187-106-306318701063030 TABLET in 1 BOTTLE (63187-106-30) 30 tablet2019-01-010000-00-00NoNoCurrent
63187-106-606318701066060 TABLET in 1 BOTTLE (63187-106-60) 60 tablet2021-11-230000-00-00NoNoCurrent
63187-106-906318701069090 TABLET in 1 BOTTLE (63187-106-90) 90 tablet2021-11-230000-00-00NoNoCurrent