Home NDC 70954-801 Tapentadol Hydrochloride
Product NDC 70954-801
11-digit product format 709540801
Labeler code 70954
Product ID 70954-801_38c1235a-d675-4b2d-b1a5-100427af2364
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tapentadol Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA219119
Marketing category ANDA
Marketing start 2026-07-13
Substance TAPENTADOL HYDROCHLORIDE
Active strength 20 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219119-001 TAPENTADOL HYDROCHLORIDE TAPENTADOL HYDROCHLORIDE EQ 20MG BASE/ML SOLUTION / ORAL 2026-01-26
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 A219119-001 TAPENTADOL HYDROCHLORIDE EQ 20MG BASE/ML SOLUTION / ORAL 2026-01-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219119-001 TAPENTADOL HYDROCHLORIDE EQ 20MG BASE/ML SOLUTION / ORAL 2026-01-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219119-001 TAPENTADOL HYDROCHLORIDE EQ 20MG BASE/ML SOLUTION / ORAL 2026-01-26 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219119-001 TAPENTADOL HYDROCHLORIDE EQ 20MG BASE/ML SOLUTION / ORAL 2026-01-26 a50c72e98297…
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 20 mg/mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1356315 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 Units Marketing start Sample Exclude flag Status 70954-801-10 70954080110 1 BOTTLE in 1 CARTON (70954-801-10) / 100 mL in 1 BOTTLE 1 bottle 2026-07-13 No No Current 70954-801-20 70954080120 1 BOTTLE in 1 CARTON (70954-801-20) / 200 mL in 1 BOTTLE 1 bottle 2026-07-13 No No Current