FDA.reportPublic FDA data

Acetaminophen And Codeine

Product NDC
67544-474
Requested package NDC
67544-474-53
11-digit product format
675440474
Labeler code
67544
Product ID
67544-474_6a62ad9a-c0ce-4848-81f3-159f525922a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen and codeine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA089828
Marketing category
ANDA
Marketing start
1988-09-30
Marketing end
0000-00-00
Substance
CODEINE PHOSPHATE; ACETAMINOPHEN
Active strength
60 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 packagepackage67544-47467544-474-53IInactivated 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 · 15 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…

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
A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A089828-001AA

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 UTC2026-02A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-09-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-09-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-09-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-09-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-09-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-303f01610625f2…
2019-09-15 20:21 UTC2019-09A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALAA1988-09-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-09-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-09-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-09-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-09-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-09-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-09-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-09-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-09-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-09-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-09-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-09-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-09-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089828-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORAL1988-09-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A089828-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089828-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089828-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089828-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089828-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089828-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089828-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089828-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089828-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089828-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089828-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089828-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089828-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089828-001AA18072bd15b7f6…
2019-12-13 00:20 UTC2019-12A089828-001AA174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089828-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A089828-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089828-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089828-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089828-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A089828-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A089828-001AA1ea99ee380514…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A089828-001AA1a50c72e98297…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
67544-474-30ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
67544-474-53ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
67544-474-60ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
67544-474-70ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
67544-474-80ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg
67544-474-90ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 mg/30 mg and 300 mg/60 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-474-30Acetaminophen And Codeine30 in 1 BOTTLE, PLASTICTABLET302
67544-474-53Acetaminophen And Codeine60 in 1 BOTTLE, PLASTICTABLET602
67544-474-60Acetaminophen And Codeine90 in 1 BOTTLE, PLASTICTABLET902
67544-474-70Acetaminophen And Codeine120 in 1 BOTTLE, PLASTICTABLET1202
67544-474-80Acetaminophen And Codeine180 in 1 BOTTLE, PLASTICTABLET1802
67544-474-90Acetaminophen And Codeine240 in 1 BOTTLE, PLASTICTABLET2402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-474-53EA - Each67544-474cc8911ae-c711-4090-94da-c63f306505bd12014-07-02
67544-474-60EA - Each67544-47468702e37-ac15-4363-9dc5-325332a36d5f12014-07-02
67544-474-70EA - Each67544-47490b69837-763d-4190-9398-bf9ed8c729ea12014-09-03
67544-474-80EA - Each67544-47413f2dac9-d309-45bd-919a-d18b59a01e7c12013-07-02
67544-474-90EA - Each67544-4747cf11aee-e6ee-48aa-a8c2-23716aabd36b12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-474ACETAMINOPHEN AND CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 6 package rows20191224_1afe1bb3-6903-4785-a121-ac8aae8653a7.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 PHOSPHATEBryant Ranch Prepack3e41e55f-7e41-4653-aadb-32a9e47962d92025-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089828
application number: ANDA089828
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEAdvanced Rx of Tennessee, LLC36988ba2-cefd-99f8-e063-6294a90aa41a2025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089828
application number: ANDA089828
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEPreferred Pharmaceuticals Inc.caa96b80-d8a7-4920-9d5c-717435e798de2025-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089828
application number: ANDA089828
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEStrides Pharma Science Limitedc459ed02-afd6-4533-82b6-bfb2c7ab0e722024-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089828
application number: ANDA089828

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN1afe1bb3-6903-4785-a121-ac8aae8653a72
993890codeine phosphate 60 MG / acetaminophen 300 MG Oral TabletPSN1afe1bb3-6903-4785-a121-ac8aae8653a72
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD1afe1bb3-6903-4785-a121-ac8aae8653a72
993890acetaminophen 300 MG / codeine phosphate 60 MG Oral TabletSCD1afe1bb3-6903-4785-a121-ac8aae8653a72
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY1afe1bb3-6903-4785-a121-ac8aae8653a72
993890APAP 300 MG / codeine phosphate 60 MG Oral TabletSY1afe1bb3-6903-4785-a121-ac8aae8653a72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67544-474-536754404745360 TABLET in 1 BOTTLE, PLASTIC (67544-474-53) 60 tablet2005-11-170000-00-00NoNoCurrent