Home NDC 71205-001-30 Acetaminophen and Codeine Phosphate
Product NDC 71205-001
Requested package NDC 71205-001-30
11-digit product format 712050001
Labeler code 71205
Product ID 71205-001_a287ed41-2a8c-4181-9d55-9994aa9b0769
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetaminophen and Codeine Phosphate
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71205-001 71205-001-30 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71205-001 71205-001-30 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-001 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [PROFICIENT RX LP] 4 Legacy NDC 20191122_337b80a6-0398-43be-bd22-288332d9c4d0.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71205-001-30 71205000130 30 TABLET in 1 BOTTLE (71205-001-30) 30 tablet 2018-06-01 0000-00-00 No No Current