Home NDC 67046-903-20 Acetaminophen and Codeine Phosphate
Product NDC 67046-903
Requested package NDC 67046-903-20
11-digit product format 670460903
Labeler code 67046
Product ID 67046-903_5a45c22c-dd1d-5bd3-e053-2991aa0aaf92
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetaminophen and Codeine Phosphate
Dosage form TABLET
Route ORAL
Labeler Contract Pharmacy Services-PA
Application ANDA088628
Marketing category ANDA
Marketing start 2017-09-28
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 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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2019-12-13 00:20 UTC 2019-12 A088628-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA 1985-03-06 74a2ff9319b5…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088628-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA 1985-03-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088628-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA 1985-03-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088628-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA 1985-03-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088628-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA 1985-03-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088628-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA 1985-03-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088628-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA 1985-03-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088628-001 ACETAMINOPHEN AND CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL AA 1985-03-06 ea99ee380514…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67046-903-07 Acetaminophen and Codeine Phosphate 7 in 1 BLISTER PACK TABLET 7 1 67046-903-14 Acetaminophen and Codeine Phosphate 14 in 1 BLISTER PACK TABLET 14 1 67046-903-15 Acetaminophen and Codeine Phosphate 15 in 1 BLISTER PACK TABLET 15 1 67046-903-20 Acetaminophen and Codeine Phosphate 20 in 1 BLISTER PACK TABLET 20 1 67046-903-21 Acetaminophen and Codeine Phosphate 21 in 1 BLISTER PACK TABLET 21 1 67046-903-28 Acetaminophen and Codeine Phosphate 28 in 1 BLISTER PACK TABLET 28 1 67046-903-30 Acetaminophen and Codeine Phosphate 30 in 1 BLISTER PACK TABLET 30 1 67046-903-60 Acetaminophen and Codeine Phosphate 60 in 1 BLISTER PACK TABLET 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67046-903 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 Legacy NDC, 8 package rows 20170929_5a45c22c-dd1c-5bd3-e053-2991aa0aaf92.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67046-903-20 67046090320 20 TABLET in 1 BLISTER PACK (67046-903-20) 20 tablet 2017-09-28 0000-00-00 No No Current