FDA.reportPublic FDA data

Tapentadol Hydrochloride

Product NDC
70954-801
Requested package NDC
70954-801-10
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 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219119-001TAPENTADOL HYDROCHLORIDETAPENTADOL HYDROCHLORIDEEQ 20MG BASE/MLSOLUTION / ORAL2026-01-26

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A219119-001TAPENTADOL HYDROCHLORIDEEQ 20MG BASE/MLSOLUTION / ORAL2026-01-26c2088c7a36db…
2026-09-14 22:38:342026-08A219119-001TAPENTADOL HYDROCHLORIDEEQ 20MG BASE/MLSOLUTION / ORAL2026-01-2684e616aacf4f…
2026-08-18 06:07:402026-07A219119-001TAPENTADOL HYDROCHLORIDEEQ 20MG BASE/MLSOLUTION / ORAL2026-01-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219119-001TAPENTADOL HYDROCHLORIDEEQ 20MG BASE/MLSOLUTION / ORAL2026-01-26011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219119-001TAPENTADOL HYDROCHLORIDEEQ 20MG BASE/MLSOLUTION / ORAL2026-01-26a50c72e98297…

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
IngredientStrength
TAPENTADOL HYDROCHLORIDE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
71204KII53Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1356315Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e0ecb809-6a55-4afe-b981-b8f174e5c344Available on FDA.report

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tapentadol HydrochlorideTAPENTADOL HYDROCHLORIDEANI Pharmaceuticals, Inc.e0ecb809-6a55-4afe-b981-b8f174e5c3442026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219119
application number: ANDA219119
ndc (package): 70954-801-10
ndc (product): 70954-801
ndc11 (package): 70954080110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70954-801-10709540801101 BOTTLE in 1 CARTON (70954-801-10) / 100 mL in 1 BOTTLE1 bottle2026-07-13NoNoCurrent