Acetaminophen and Codeine Phosphate

Product NDC
71335-0701
Requested package NDC
71335-0701-3
11-digit product format
713350701
Labeler code
71335
Product ID
71335-0701_b3eeebc3-05cf-4e86-bdef-5d721e79d1fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA088629
Marketing category
ANDA
Marketing start
1990-09-30
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
2023-12-31
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 packagepackage71335-070171335-0701-3DDiscontinued by firm2026-10-05

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 43.

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
A088629-001ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;60MGTABLET / ORALRLD1985-03-06
A088629-002ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1985-03-06
A088629-003ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN; CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1985-03-06

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 3 · 113 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A088629-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALRLD1985-03-0684e616aacf4f…
2026-09-14 22:38:342026-08A088629-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1985-03-0684e616aacf4f…
2026-09-14 22:38:342026-08A088629-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1985-03-0684e616aacf4f…
2026-08-18 06:07:402026-07A088629-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALRLD1985-03-06caaa826d4ba7…
2026-08-18 06:07:402026-07A088629-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1985-03-06caaa826d4ba7…
2026-08-18 06:07:402026-07A088629-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1985-03-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A088629-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALRLD1985-03-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A088629-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1985-03-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A088629-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1985-03-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088629-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALRLD1985-03-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088629-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1985-03-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088629-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1985-03-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A088629-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALRLD1985-03-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A088629-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1985-03-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A088629-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1985-03-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088629-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALRLD1985-03-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088629-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1985-03-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088629-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1985-03-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088629-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALRLD1985-03-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088629-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1985-03-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088629-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1985-03-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088629-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALRLD1985-03-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088629-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1985-03-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088629-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1985-03-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088629-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALRLD1985-03-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088629-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1985-03-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088629-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1985-03-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088629-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALRLD1985-03-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088629-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1985-03-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088629-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1985-03-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088629-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALRLD1985-03-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088629-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1985-03-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088629-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1985-03-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088629-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALRLD1985-03-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A088629-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1985-03-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A088629-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1985-03-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088629-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALRLD1985-03-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088629-002ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;15MGTABLET / ORAL1985-03-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088629-003ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORAL1985-03-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088629-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;60MGTABLET / ORALRLD1985-03-06301d65b070ca…

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
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088629-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088629-002AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088629-003AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088629-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A088629-002AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A088629-003AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088629-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A088629-002AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A088629-003AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088629-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088629-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A088629-002AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A088629-003AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088629-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A088629-002AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A088629-003AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088629-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A088629-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088629-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088629-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088629-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A088629-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A088629-001AA1ea99ee380514…
2023-05-13 08:27 UTC2023-05A088629-001AA1053a50430f4f…
2023-05-13 08:27 UTC2023-05A088629-002AA1053a50430f4f…
2023-05-13 08:27 UTC2023-05A088629-003AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A088629-001AA13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A088629-002AA13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A088629-003AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088629-001AA13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088629-002AA13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088629-003AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088629-001AA1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A088629-002AA1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A088629-003AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088629-001AA1e64feba35796…
2022-09-29 23:25 UTC2022-09A088629-002AA1e64feba35796…
2022-09-29 23:25 UTC2022-09A088629-003AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088629-001AA1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088629-002AA1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

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

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0701-0Acetaminophen and Codeine Phosphate100 in 1 BOTTLETABLET1004
71335-0701-1Acetaminophen and Codeine Phosphate30 in 1 BOTTLETABLET304
71335-0701-2Acetaminophen and Codeine Phosphate120 in 1 BOTTLETABLET1204
71335-0701-3Acetaminophen and Codeine Phosphate60 in 1 BOTTLETABLET604
71335-0701-4Acetaminophen and Codeine Phosphate90 in 1 BOTTLETABLET904
71335-0701-5Acetaminophen and Codeine Phosphate40 in 1 BOTTLETABLET404
71335-0701-6Acetaminophen and Codeine Phosphate20 in 1 BOTTLETABLET204
71335-0701-7Acetaminophen and Codeine Phosphate112 in 1 BOTTLETABLET1124
71335-0701-8Acetaminophen and Codeine Phosphate84 in 1 BOTTLETABLET844
71335-0701-9Acetaminophen and Codeine Phosphate15 in 1 BOTTLETABLET154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0701-3EA - Each71335-0701feef7df3-da34-4eed-9444-eb099b155bc512018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0701ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]4Legacy NDC, 10 package rows20220129_b3eeebc3-05cf-4e86-bdef-5d721e79d1fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993890codeine phosphate 60 MG / acetaminophen 300 MG Oral TabletPSNb3eeebc3-05cf-4e86-bdef-5d721e79d1fe4
993890acetaminophen 300 MG / codeine phosphate 60 MG Oral TabletSCDb3eeebc3-05cf-4e86-bdef-5d721e79d1fe4
993890APAP 300 MG / codeine phosphate 60 MG Oral TabletSYb3eeebc3-05cf-4e86-bdef-5d721e79d1fe4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0701-37133507010360 TABLET in 1 BOTTLE (71335-0701-3) 60 tablet2018-02-270000-00-00NoNoCurrent