Acetaminophen and Codeine

Product NDC
65162-033
11-digit product format
651620033
Labeler code
65162
Product ID
65162-033_75a6d334-42b8-44d0-a4a1-fd3eeb95008f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA040779
Marketing category
ANDA
Marketing start
2008-05-29
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 · 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…

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen and Codeine
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
8bc4108b-314e-4a52-a37c-631c6b869b04Available on FDA.report

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
65162-033-10Acetaminophen and Codeine100 in 1 BOTTLETABLET10046
65162-033-11Acetaminophen and Codeine1000 in 1 BOTTLETABLET100046
65162-033-50Acetaminophen and Codeine500 in 1 BOTTLETABLET50046

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-033-10EA - Each65162-033c3ea83ce-d04c-4f7a-9ecf-8b2211dbf70a12013-02-13
65162-033-11EA - Each65162-0339cadd470-f260-4cee-ae32-0ba16c1e325c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE (CODEINE PHOSPHATE AND APAP) TABLET [NORTHWIND PHARMACEUTICALS, LLC]3
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE (CODEINE PHOSPHATE AND APAP) TABLET [NORTHWIND PHARMACEUTICALS, LLC]3
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE (CODEINE PHOSPHATE AND APAP) TABLET [NORTHWIND PHARMACEUTICALS, LLC]3
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE (CODEINE PHOSPHATE AND APAP) TABLET [NORTHWIND PHARMACEUTICALS, LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN AND CODEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACETAMINOPHEN AND CODEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACETAMINOPHEN AND CODEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN AND CODEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
CODEINEACTIVE INGREDIENTQ830PW7520ACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES]2
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE TABLET [RXCHANGE CO.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN AND CODEINE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-033ACETAMINOPHEN AND CODEINE TABLET [AMNEAL PHARMACEUTICALS LLC]43Current NDC, Legacy NDC, 3 package rows20240228_8bc4108b-314e-4a52-a37c-631c6b869b04.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
ndc (product): 65162-033
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 TabletPSN8bc4108b-314e-4a52-a37c-631c6b869b0446
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD8bc4108b-314e-4a52-a37c-631c6b869b0446
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY8bc4108b-314e-4a52-a37c-631c6b869b0446
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN720570a4-9eec-41c8-ae69-37189756c31815
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD720570a4-9eec-41c8-ae69-37189756c31815
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY720570a4-9eec-41c8-ae69-37189756c31815
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSNc8284691-86f6-4ce0-b680-addc29b35fa613
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCDc8284691-86f6-4ce0-b680-addc29b35fa613
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSYc8284691-86f6-4ce0-b680-addc29b35fa613
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN7d940b9c-7406-4182-9052-c6a5806337a08
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD7d940b9c-7406-4182-9052-c6a5806337a08
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY7d940b9c-7406-4182-9052-c6a5806337a08
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN5970383b-06a3-45e7-9e93-41213a4f9b5d5
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSNa35b4ba3-43c0-73c8-e053-2a95a90af5b55
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD5970383b-06a3-45e7-9e93-41213a4f9b5d5
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCDa35b4ba3-43c0-73c8-e053-2a95a90af5b55
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY5970383b-06a3-45e7-9e93-41213a4f9b5d5
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSYa35b4ba3-43c0-73c8-e053-2a95a90af5b55
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN2472bb8a-88b7-4eec-8806-34adef0c9ab94
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD2472bb8a-88b7-4eec-8806-34adef0c9ab94
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY2472bb8a-88b7-4eec-8806-34adef0c9ab94
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSNb84d3e24-693d-4667-ae35-0583b63686103
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCDb84d3e24-693d-4667-ae35-0583b63686103
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSYb84d3e24-693d-4667-ae35-0583b63686103
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN57f985e3-9572-477f-e053-2991aa0a61c91
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN3f83ba75-9415-4ace-9416-04d666c005a21
993781codeine phosphate 30 MG / acetaminophen 300 MG Oral TabletPSN894b2958-a67f-42bc-9b49-ba54008116951
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD894b2958-a67f-42bc-9b49-ba54008116951
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD3f83ba75-9415-4ace-9416-04d666c005a21
993781acetaminophen 300 MG / codeine phosphate 30 MG Oral TabletSCD57f985e3-9572-477f-e053-2991aa0a61c91
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY3f83ba75-9415-4ace-9416-04d666c005a21
993781APAP 300 MG / codeine phosphate 30 MG Oral TabletSY894b2958-a67f-42bc-9b49-ba54008116951
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
65162-033-1065162003310100 TABLET in 1 BOTTLE (65162-033-10) 100 tablet2008-05-290000-00-00NoNoCurrent
65162-033-11651620033111000 TABLET in 1 BOTTLE (65162-033-11) 1000 tablet2008-05-290000-00-00NoNoCurrent
65162-033-5065162003350500 TABLET in 1 BOTTLE (65162-033-50) 500 tablet2008-05-290000-00-00NoNoCurrent