FDA.reportPublic FDA data

Acetaminophen and Codeine Phosphate

Product NDC
64850-641
11-digit product format
648500641
Labeler code
64850
Product ID
64850-641_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; 15 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212418-001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2019-09-10
A212418-002ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2019-09-10
A212418-003ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2019-09-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A212418-001AA
A212418-002AA
A212418-003AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A212418-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2019-09-10c2088c7a36db…
2026-10-15 13:18:302026-09A212418-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2019-09-10c2088c7a36db…
2026-10-15 13:18:302026-09A212418-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2019-09-10c2088c7a36db…
2026-09-14 22:38:342026-08A212418-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2019-09-1084e616aacf4f…
2026-09-14 22:38:342026-08A212418-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2019-09-1084e616aacf4f…
2026-09-14 22:38:342026-08A212418-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2019-09-1084e616aacf4f…
2026-08-18 06:07:402026-07A212418-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2019-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07A212418-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2019-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07A212418-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2019-09-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212418-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2019-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212418-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2019-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212418-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2019-09-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212418-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2019-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212418-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2019-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212418-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2019-09-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A212418-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2019-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212418-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2019-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212418-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2019-09-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212418-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2019-09-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212418-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2019-09-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212418-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2019-09-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212418-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2019-09-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212418-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2019-09-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212418-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2019-09-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212418-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2019-09-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212418-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2019-09-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212418-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2019-09-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212418-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2019-09-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212418-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2019-09-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212418-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2019-09-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212418-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2019-09-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212418-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2019-09-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212418-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2019-09-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212418-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2019-09-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212418-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2019-09-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212418-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2019-09-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212418-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2019-09-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A212418-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2019-09-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A212418-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2019-09-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212418-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2019-09-1079d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-09-29 23:25 UTC2022-09A212418-001AA1e64feba35796…
2022-09-29 23:25 UTC2022-09A212418-002AA1e64feba35796…
2022-09-29 23:25 UTC2022-09A212418-003AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212418-001AA1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212418-002AA1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212418-003AA1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212418-001AA1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212418-002AA1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212418-003AA1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen and Codeine Phosphate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN300 mg/1
CODEINE PHOSPHATE15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
GSL05Y1MN6Internal UNII lookup
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
993770Internal RxNorm lookup
993781Internal RxNorm lookup
993890Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6286e128-1288-4dc0-b14b-f04a0e2a22f9Available on FDA.report

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
64850-641-01Acetaminophen and Codeine Phosphate100 in 1 BOTTLETABLET10017
64850-641-05Acetaminophen and Codeine Phosphate500 in 1 BOTTLETABLET50017
64850-641-12Acetaminophen and Codeine Phosphate120 in 1 BOTTLETABLET12017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64850-641-01EA - Each64850-641b17b8b61-dd6c-4824-90b5-9fba4a9538e212024-11-05
64850-641-05EA - Each64850-641709d57f9-6be9-4bca-b33e-f5d12c3ab64512025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64850-641ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [ELITE LABORATORIES, INC.]14Current NDC, Legacy NDC, 3 package rows20250417_6286e128-1288-4dc0-b14b-f04a0e2a22f9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEProficient Rx LP6980bfc5-15e4-48ec-9346-6f09f8f789002026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212418
application number: ANDA212418
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEElite Laboratories, Inc.6286e128-1288-4dc0-b14b-f04a0e2a22f92025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212418
application number: ANDA212418
ndc (product): 64850-641
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEAdvanced Rx of Tennessee, LLC3698e0ff-6a1c-e1ad-e063-6294a90a163a2025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212418
application number: ANDA212418
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals, Inc.2e88442f-a6a9-a899-e063-6294a90ac08d2025-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212418
application number: ANDA212418

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64850-641-0164850064101100 TABLET in 1 BOTTLE (64850-641-01) 100 tablet2024-05-03NoNoCurrent
64850-641-0564850064105500 TABLET in 1 BOTTLE (64850-641-05) 500 tablet2025-02-10NoNoCurrent
64850-641-1264850064112120 TABLET in 1 BOTTLE (64850-641-12) 120 tablet2019-09-100000-00-00NoNoCurrent