FDA.reportPublic FDA data

Acetaminophen and Codeine Phosphate

Product NDC
63187-815
11-digit product format
631870815
Labeler code
63187
Product ID
63187-815_5dde8fb0-3744-4a96-89c4-5b891681ccd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202800
Marketing category
ANDA
Marketing start
2017-01-05
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A202800-001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2013-04-15
A202800-002ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2013-04-15
A202800-003ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2013-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202800-001AA
A202800-002AA
A202800-003AA

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202800-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2013-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202800-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2013-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202800-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2013-04-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202800-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2013-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202800-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2013-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202800-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2013-04-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A202800-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2013-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202800-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2013-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202800-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2013-04-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202800-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2013-04-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202800-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2013-04-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202800-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2013-04-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202800-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2013-04-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202800-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2013-04-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202800-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2013-04-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202800-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2013-04-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202800-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2013-04-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202800-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2013-04-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202800-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2013-04-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202800-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2013-04-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202800-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2013-04-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202800-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2013-04-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202800-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2013-04-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202800-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2013-04-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202800-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2013-04-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202800-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2013-04-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202800-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2013-04-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202800-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2013-04-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A202800-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2013-04-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A202800-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2013-04-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202800-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2013-04-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202800-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2013-04-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202800-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2013-04-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202800-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2013-04-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202800-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2013-04-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202800-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2013-04-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202800-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2013-04-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202800-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2013-04-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202800-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA2013-04-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202800-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORALAA2013-04-158072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202800-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202800-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202800-003AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202800-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202800-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202800-003AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202800-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202800-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202800-003AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202800-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202800-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202800-003AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202800-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202800-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202800-003AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202800-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202800-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202800-003AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202800-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202800-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202800-003AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202800-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202800-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202800-003AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202800-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202800-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202800-003AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202800-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202800-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202800-003AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202800-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202800-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202800-003AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202800-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202800-002AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202800-003AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202800-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202800-002AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202800-003AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202800-001AA18072bd15b7f6…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEAurolife Pharma, LLC02386806-02d4-47e3-9c8b-7810146ee7952025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202800
application number: ANDA202800
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack30da1bea-2dbc-4086-a5cf-8ed471bb65932024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202800
application number: ANDA202800
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEBryant Ranch Prepack9f2127d9-d60b-42d3-9b6c-798e63dd68d12024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202800
application number: ANDA202800
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.8f12016d-904f-00b4-e053-2a95a90ad02a2024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202800
application number: ANDA202800
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.80c9a58d-98ae-5497-e053-2991aa0a61fb2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202800
application number: ANDA202800
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATENuCare Pharmaceuticals,Inc.7d69403e-90d0-7a80-e053-2a91aa0a55522024-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202800
application number: ANDA202800
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEProficient Rx LP75b50751-5237-4e3e-b7ee-1605c0602f3b2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202800
application number: ANDA202800
ndc (product): 63187-815

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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
75b50751-5237-4e3e-b7ee-1605c0602f3bAvailable 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
63187-815-15Acetaminophen and Codeine Phosphate15 in 1 BOTTLETABLET156
63187-815-20Acetaminophen and Codeine Phosphate20 in 1 BOTTLETABLET206
63187-815-30Acetaminophen and Codeine Phosphate30 in 1 BOTTLETABLET306
63187-815-60Acetaminophen and Codeine Phosphate60 in 1 BOTTLETABLET606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-815-15EA - Each63187-8156f2f625e-43fb-4105-b2fb-a2fb38dddde812020-08-06
63187-815-20EA - Each63187-81539aedde1-6947-46dd-ab56-5a8e36541e4e12017-03-06
63187-815-30EA - Each63187-81598fcc02a-c937-4496-890f-c7bda9d76d1c12017-03-06
63187-815-60EA - Each63187-8152d409540-239d-49d0-8724-859863cfebce12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-815ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 4 package rows20220420_75b50751-5237-4e3e-b7ee-1605c0602f3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN75b50751-5237-4e3e-b7ee-1605c0602f3b6
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD75b50751-5237-4e3e-b7ee-1605c0602f3b6
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY75b50751-5237-4e3e-b7ee-1605c0602f3b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-815-156318708151515 TABLET in 1 BOTTLE (63187-815-15) 15 tablet2020-05-280000-00-00NoNoCurrent
63187-815-206318708152020 TABLET in 1 BOTTLE (63187-815-20) 20 tablet2017-02-010000-00-00NoNoCurrent
63187-815-306318708153030 TABLET in 1 BOTTLE (63187-815-30) 30 tablet2017-02-010000-00-00NoNoCurrent
63187-815-606318708156060 TABLET in 1 BOTTLE (63187-815-60) 60 tablet2017-02-010000-00-00NoNoCurrent