FDA.reportPublic FDA data

Acetaminophen and Codeine Phosphate

Product NDC
64850-642
11-digit product format
648500642
Labeler code
64850
Product ID
64850-642_d61159a3-cb34-4931-8185-e1eb41654a8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Elite Laboratories, Inc.
Application
ANDA212418
Marketing category
ANDA
Marketing start
2019-09-10
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
Rxcui993770, 993781, 993890

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
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
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64850-642-01Acetaminophen and Codeine Phosphate100 in 1 BOTTLETABLET10017
64850-642-05Acetaminophen and Codeine Phosphate500 in 1 BOTTLETABLET50017
64850-642-12Acetaminophen and Codeine Phosphate120 in 1 BOTTLETABLET12017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64850-642-01EA - Each64850-64244463f35-c580-437c-a8c4-e4a1eedfd76b12024-11-05
64850-642-05EA - Each64850-6424fdeb964-fd8a-4025-a932-062c960a0dc212025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64850-642ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [ELITE LABORATORIES, INC.]14Current NDC, Legacy NDC, 3 package rows20250417_6286e128-1288-4dc0-b14b-f04a0e2a22f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993770codeine phosphate 15 MG / acetaminophen 300 MG Oral TabletPSN6286e128-1288-4dc0-b14b-f04a0e2a22f917
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN6286e128-1288-4dc0-b14b-f04a0e2a22f917
993890codeine phosphate 60 MG / acetaminophen 300 MG Oral TabletPSN6286e128-1288-4dc0-b14b-f04a0e2a22f917
993770acetaminophen 300 MG / codeine phosphate 15 MG Oral TabletSCD6286e128-1288-4dc0-b14b-f04a0e2a22f917
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD6286e128-1288-4dc0-b14b-f04a0e2a22f917
993890acetaminophen 300 MG / codeine phosphate 60 MG Oral TabletSCD6286e128-1288-4dc0-b14b-f04a0e2a22f917
993770APAP 300 MG / codeine phosphate 15 MG Oral TabletSY6286e128-1288-4dc0-b14b-f04a0e2a22f917
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY6286e128-1288-4dc0-b14b-f04a0e2a22f917
993890APAP 300 MG / codeine phosphate 60 MG Oral TabletSY6286e128-1288-4dc0-b14b-f04a0e2a22f917
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN6980bfc5-15e4-48ec-9346-6f09f8f789002
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD6980bfc5-15e4-48ec-9346-6f09f8f789002
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY6980bfc5-15e4-48ec-9346-6f09f8f789002
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN3698e0ff-6a1c-e1ad-e063-6294a90a163a1
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN2e88442f-a6a9-a899-e063-6294a90ac08d1
993890codeine phosphate 60 MG / acetaminophen 300 MG Oral TabletPSN3698e0ff-6a1c-e1ad-e063-6294a90a163a1
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD3698e0ff-6a1c-e1ad-e063-6294a90a163a1
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD2e88442f-a6a9-a899-e063-6294a90ac08d1
993890acetaminophen 300 MG / codeine phosphate 60 MG Oral TabletSCD3698e0ff-6a1c-e1ad-e063-6294a90a163a1
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY3698e0ff-6a1c-e1ad-e063-6294a90a163a1
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY2e88442f-a6a9-a899-e063-6294a90ac08d1
993890APAP 300 MG / codeine phosphate 60 MG Oral TabletSY3698e0ff-6a1c-e1ad-e063-6294a90a163a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64850-642-0164850064201100 TABLET in 1 BOTTLE (64850-642-01) 100 tablet2024-05-03NoNoHistorical
64850-642-0564850064205500 TABLET in 1 BOTTLE (64850-642-05) 500 tablet2025-02-10NoNoHistorical
64850-642-1264850064212120 TABLET in 1 BOTTLE (64850-642-12) 120 tablet2019-09-100000-00-00NoNoCurrent