Home NDC 72205-371 Tapentadol Hydrochloride
Product NDC 72205-371
11-digit product format 722050371
Labeler code 72205
Product ID 72205-371_d4c5938a-68f0-46d2-9bad-8988d5724b09
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tapentadol Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Novadoz Pharmaceuticals LLC
Application ANDA220865
Marketing category ANDA
Marketing start 2026-09-03
Substance TAPENTADOL HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule CII
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220865-001 TAPENTADOL HYDROCHLORIDE TAPENTADOL HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2026-09-03 A220865-002 TAPENTADOL HYDROCHLORIDE TAPENTADOL HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2026-09-03 A220865-003 TAPENTADOL HYDROCHLORIDE TAPENTADOL HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2026-09-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 2026-09-14 22:38:34 2026-08 A220865-001 TAPENTADOL HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2026-09-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A220865-002 TAPENTADOL HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2026-09-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A220865-003 TAPENTADOL HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2026-09-03 84e616aacf4f…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Tapentadol Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TAPENTADOL HYDROCHLORIDE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 71204KII53 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 825409 Internal RxNorm lookup 825411 Internal RxNorm lookup 825413 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72205-371-91 72205037191 100 TABLET, FILM COATED in 1 BOTTLE (72205-371-91) 2026-09-03 No No Current