Home NDC 71993-300-30 Acetaminophen, Caffeine and Dihydrocodeine Bitartrate
Product NDC 71993-300
Requested package NDC 71993-300-30
11-digit product format 719930300
Labeler code 71993
Product ID 71993-300_9d4d2838-e33e-6544-e053-2a95a90aaf51
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetaminophen, Caffeine and Dihydrocodeine Bitartrate
Dosage form TABLET
Route ORAL
Labeler Atland Pharmaceuticals, LLC
Application ANDA204209
Marketing category ANDA
Marketing start 2020-01-30
Marketing end 0000-00-00
Substance ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
Active strength 325 mg/1; mg/1; mg/1
Pharmacologic classes Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204209-001 ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE 325MG;30MG;16MG TABLET / ORAL 2016-09-30
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 2026-08-01 22:54:32 2026-06 A204209-001 ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE 325MG;30MG;16MG TABLET / ORAL 2016-09-30 a50c72e98297…
FDA-Initiated Inactive NDC Indexing# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71993-300-30 71993030030 30 TABLET in 1 BOTTLE, PLASTIC (71993-300-30) 30 tablet 2020-01-30 0000-00-00 No No Current