FDA.reportPublic FDA data

Tapentadol Hydrochloride

Product NDC
42806-628
11-digit product format
428060628
Labeler code
42806
Product ID
42806-628_120aa46b-8c91-4460-8e91-85cbaac53d20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tapentadol Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
EPIC PHARMA LLC
Application
ANDA214378
Marketing category
ANDA
Marketing start
2021-12-31
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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214378-001TAPENTADOL HYDROCHLORIDETAPENTADOL HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2026-01-27
A214378-002TAPENTADOL HYDROCHLORIDETAPENTADOL HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2026-01-27
A214378-003TAPENTADOL HYDROCHLORIDETAPENTADOL HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2026-01-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A214378-001AB
A214378-002AB
A214378-003AB

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
2026-02-19 14:30 UTC2026-02A214378-001TAPENTADOL HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2026-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214378-002TAPENTADOL HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2026-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214378-003TAPENTADOL HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2026-01-27011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214378-001TAPENTADOL HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2026-01-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214378-002TAPENTADOL HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2026-01-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214378-003TAPENTADOL HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2026-01-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214378-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214378-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214378-003AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214378-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214378-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214378-003AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Tapentadol Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAPENTADOL HYDROCHLORIDE100 mg/1

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
825409Internal RxNorm lookup
825411Internal RxNorm lookup
825413Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fecd2104-5bf3-47ed-a6f0-5c6ebb0a17b4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
279f6ab2-ad0d-a4be-abc3-377fa3441fa2Product name120140508
41331914-7851-9471-14c3-fea0cf65689eProduct name120140508
7142c439-ef45-40fb-d30b-dd20e4faf1c1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-628-01Tapentadol Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-628-01EA - Each42806-628e546a2d0-fd93-4607-b062-0fbf11c0ed5b12026-03-17

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 HYDROCHLORIDEEPIC PHARMA LLCfecd2104-5bf3-47ed-a6f0-5c6ebb0a17b42026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214378
application number: ANDA214378
ndc (product): 42806-628

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
825409tapentadol 100 MG Oral TabletPSNfecd2104-5bf3-47ed-a6f0-5c6ebb0a17b49
825411tapentadol 50 MG Oral TabletPSNfecd2104-5bf3-47ed-a6f0-5c6ebb0a17b49
825413tapentadol 75 MG Oral TabletPSNfecd2104-5bf3-47ed-a6f0-5c6ebb0a17b49
825409tapentadol 100 MG Oral TabletSCDfecd2104-5bf3-47ed-a6f0-5c6ebb0a17b49
825411tapentadol 50 MG Oral TabletSCDfecd2104-5bf3-47ed-a6f0-5c6ebb0a17b49
825413tapentadol 75 MG Oral TabletSCDfecd2104-5bf3-47ed-a6f0-5c6ebb0a17b49
825409tapentadol 100 MG (as tapentadol hydrochloride) Oral TabletSYfecd2104-5bf3-47ed-a6f0-5c6ebb0a17b49
825411tapentadol 50 MG (as tapentadol hydrochloride) Oral TabletSYfecd2104-5bf3-47ed-a6f0-5c6ebb0a17b49
825413tapentadol 75 MG (as tapentadol hydrochloride) Oral TabletSYfecd2104-5bf3-47ed-a6f0-5c6ebb0a17b49

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42806-628-0142806062801100 TABLET, FILM COATED in 1 BOTTLE (42806-628-01) 2021-12-31NoNoCurrent