Acetaminophen and Codeine

Product NDC
67046-908
Requested package NDC
67046-908-30
11-digit product format
670460908
Labeler code
67046
Product ID
67046-908_57f985e3-9573-477f-e053-2991aa0a61c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA040779
Marketing category
ANDA
Marketing start
2008-05-29
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength
300 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67046-90867046-908-30IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040779-001AA

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-293f01610625f2…
2019-09-15 20:21 UTC2019-09A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040779-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA2008-05-29cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040779-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040779-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040779-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040779-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040779-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040779-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040779-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040779-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040779-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040779-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040779-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040779-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040779-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040779-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040779-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040779-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040779-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040779-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040779-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040779-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040779-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040779-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040779-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040779-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040779-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040779-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040779-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040779-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040779-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040779-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040779-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040779-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040779-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040779-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040779-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040779-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040779-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040779-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040779-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040779-001AA1cb3db0bc1861…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-908-302022-01-28C16284748780-1d6a99b39-8293-a426-e053-dadaa90af4c2Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-908-30Acetaminophen and Codeine30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-908ACETAMINOPHEN AND CODEINE TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20170830_57f985e3-9572-477f-e053-2991aa0a61c9.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen and CodeineACETAMINOPHEN AND CODEINEBryant Ranch Prepack7d940b9c-7406-4182-9052-c6a5806337a02026-05-06Boxed warning, WarningsExact identifier
application applno (ANDA): 040779
application number: ANDA040779
Acetaminophen and CodeineACETAMINOPHEN AND CODEINEAmneal Pharmaceuticals LLC8bc4108b-314e-4a52-a37c-631c6b869b042025-12-01Boxed warning, WarningsExact identifier
application applno (ANDA): 040779
application number: ANDA040779
Acetaminophen and CodeineACETAMINOPHEN AND CODEINERedPharm Drug, Inc.a35b4ba3-43c0-73c8-e053-2a95a90af5b52025-04-09Boxed warning, WarningsExact identifier
application applno (ANDA): 040779
application number: ANDA040779
Acetaminophen and CodeineACETAMINOPHEN AND CODEINEProficient Rx LP2472bb8a-88b7-4eec-8806-34adef0c9ab92021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040779
application number: ANDA040779
Acetaminophen and CodeineACETAMINOPHEN AND CODEINEAsclemed USA, Inc.3f83ba75-9415-4ace-9416-04d666c005a22020-10-30Boxed warning, WarningsExact identifier
application applno (ANDA): 040779
application number: ANDA040779

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN57f985e3-9572-477f-e053-2991aa0a61c91
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD57f985e3-9572-477f-e053-2991aa0a61c91
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY57f985e3-9572-477f-e053-2991aa0a61c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-908-306704609083030 TABLET in 1 BLISTER PACK (67046-908-30) 30 tablet2008-05-290000-00-00NoNoCurrent