FDA.reportPublic FDA data

Acetaminophen and Codeine Phosphate

Product NDC
63629-1494
Requested package NDC
63629-1494-8
11-digit product format
636291494
Labeler code
63629
Product ID
63629-1494_898491ae-5708-43c1-9632-47a64db42ecf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen and Codeine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA088628
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
2021-12-31
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 packagepackage63629-149463629-1494-8DDiscontinued 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 · 12 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…

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12A088628-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1985-03-0674a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088628-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1985-03-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A088628-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1985-03-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088628-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1985-03-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088628-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1985-03-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088628-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1985-03-063f01610625f2…
2019-09-15 20:21 UTC2019-09A088628-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1985-03-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A088628-001ACETAMINOPHEN AND CODEINE PHOSPHATE300MG;30MGTABLET / ORALAA1985-03-06ea99ee380514…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A088628-001AA174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088628-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A088628-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088628-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088628-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088628-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A088628-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A088628-001AA1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1494-0EA - Each63629-1494b86d13f7-940f-4972-b2fd-fcc17c4022d912013-02-13
63629-1494-1EA - Each63629-14941c6441bc-59d1-4002-b34a-cda7ec07478f12013-02-13
63629-1494-2EA - Each63629-1494ba9bbbf1-fd33-4fc4-98f6-039fb1aa262512013-02-13
63629-1494-3EA - Each63629-149489d55af5-cff5-4fa5-ac96-94e13dac99c712013-02-13
63629-1494-4EA - Each63629-149415d80cd1-90da-47ca-85b5-3ed68de5da5412013-02-13
63629-1494-5EA - Each63629-1494ede9595b-9bec-46d3-b827-71e04d56279e12013-02-13
63629-1494-6EA - Each63629-1494b7868bca-acbb-4d79-ad4c-f6bbeb4096b112013-02-13
63629-1494-7EA - Each63629-14949af567be-565c-4dff-89e9-89717a2c64a912013-02-13
63629-1494-8EA - Each63629-149484d0d49d-8168-49b2-b6e6-d5b2960772e812013-02-13
63629-1494-9EA - Each63629-1494cc48c9f1-7c04-4b04-a140-becfc4ff585412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]1000
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]1000
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]1000
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]1000
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [BRYANT RANCH PREPACK]1000

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1494-86362914940860 TABLET in 1 BOTTLE (63629-1494-8) 60 tablet2005-10-070000-00-00NoNoCurrent