Hydrocodone Bitartrate

Product NDC
47781-396
11-digit product format
477810396
Labeler code
47781
Product ID
47781-396_271ec71a-ed16-53cb-f7a8-8d10949ec504
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Alvogen Inc.
Application
ANDA208269
Marketing category
ANDA
Marketing start
2021-03-03
Substance
HYDROCODONE BITARTRATE
Active strength
80 mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208269-001HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE20MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01
A208269-002HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE30MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01
A208269-003HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE40MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01
A208269-004HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE60MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01
A208269-005HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE80MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01
A208269-006HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE100MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01
A208269-007HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE120MGTABLET, EXTENDED RELEASE / ORAL2021-03-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A208269-001AB
A208269-002AB
A208269-003AB
A208269-004AB
A208269-005AB
A208269-006AB

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.

Product history page 1 of 6 · 238 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208269-001HYDROCODONE BITARTRATE20MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208269-002HYDROCODONE BITARTRATE30MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208269-003HYDROCODONE BITARTRATE40MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208269-004HYDROCODONE BITARTRATE60MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208269-005HYDROCODONE BITARTRATE80MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208269-006HYDROCODONE BITARTRATE100MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208269-007HYDROCODONE BITARTRATE120MGTABLET, EXTENDED RELEASE / ORAL2021-03-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208269-001HYDROCODONE BITARTRATE20MGTABLET, EXTENDED RELEASE / ORALAB2021-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208269-002HYDROCODONE BITARTRATE30MGTABLET, EXTENDED RELEASE / ORALAB2021-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208269-003HYDROCODONE BITARTRATE40MGTABLET, EXTENDED RELEASE / ORALAB2021-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208269-004HYDROCODONE BITARTRATE60MGTABLET, EXTENDED RELEASE / ORALAB2021-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208269-005HYDROCODONE BITARTRATE80MGTABLET, EXTENDED RELEASE / ORALAB2021-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208269-006HYDROCODONE BITARTRATE100MGTABLET, EXTENDED RELEASE / ORALAB2021-03-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208269-007HYDROCODONE BITARTRATE120MGTABLET, EXTENDED RELEASE / ORAL2021-03-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208269-001HYDROCODONE BITARTRATE20MGTABLET, EXTENDED RELEASE / ORALAB2021-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208269-002HYDROCODONE BITARTRATE30MGTABLET, EXTENDED RELEASE / ORALAB2021-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208269-003HYDROCODONE BITARTRATE40MGTABLET, EXTENDED RELEASE / ORALAB2021-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208269-004HYDROCODONE BITARTRATE60MGTABLET, EXTENDED RELEASE / ORALAB2021-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208269-005HYDROCODONE BITARTRATE80MGTABLET, EXTENDED RELEASE / ORALAB2021-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208269-006HYDROCODONE BITARTRATE100MGTABLET, EXTENDED RELEASE / ORALAB2021-03-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208269-007HYDROCODONE BITARTRATE120MGTABLET, EXTENDED RELEASE / ORAL2021-03-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208269-001HYDROCODONE BITARTRATE20MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208269-002HYDROCODONE BITARTRATE30MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208269-003HYDROCODONE BITARTRATE40MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208269-004HYDROCODONE BITARTRATE60MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208269-005HYDROCODONE BITARTRATE80MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208269-006HYDROCODONE BITARTRATE100MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208269-007HYDROCODONE BITARTRATE120MGTABLET, EXTENDED RELEASE / ORAL2021-03-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208269-001HYDROCODONE BITARTRATE20MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208269-002HYDROCODONE BITARTRATE30MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208269-003HYDROCODONE BITARTRATE40MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208269-004HYDROCODONE BITARTRATE60MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208269-005HYDROCODONE BITARTRATE80MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208269-006HYDROCODONE BITARTRATE100MGTABLET, EXTENDED RELEASE / ORALAB2021-03-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208269-007HYDROCODONE BITARTRATE120MGTABLET, EXTENDED RELEASE / ORAL2021-03-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208269-001HYDROCODONE BITARTRATE20MGTABLET, EXTENDED RELEASE / ORALAB2021-03-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208269-002HYDROCODONE BITARTRATE30MGTABLET, EXTENDED RELEASE / ORALAB2021-03-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208269-003HYDROCODONE BITARTRATE40MGTABLET, EXTENDED RELEASE / ORALAB2021-03-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208269-004HYDROCODONE BITARTRATE60MGTABLET, EXTENDED RELEASE / ORALAB2021-03-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208269-005HYDROCODONE BITARTRATE80MGTABLET, EXTENDED RELEASE / ORALAB2021-03-0103ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 231 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208269-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208269-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208269-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208269-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208269-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208269-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208269-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208269-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208269-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208269-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208269-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208269-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208269-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208269-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208269-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208269-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208269-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208269-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208269-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208269-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208269-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208269-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208269-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208269-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208269-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208269-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208269-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208269-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208269-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208269-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208269-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208269-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208269-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208269-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208269-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208269-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208269-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208269-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208269-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208269-004AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocodone Bitartrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCODONE BITARTRATE80 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NO70W886KKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1595730Internal RxNorm lookup
1595740Internal RxNorm lookup
1595746Internal RxNorm lookup
1595752Internal RxNorm lookup
1595758Internal RxNorm lookup
1595764Internal RxNorm lookup
1595770Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f7b55d14-0980-b680-8ceb-7489ff65455eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
7855f8e3-562e-4273-8b79-0059c07a71f7Product name120170901
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
a5244f9c-cd67-0e27-d63b-65fd7e584400Product name220170504
b654f2d9-ebeb-451d-96ee-22f583344623Product name120170424
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47781-396-60Hydrocodone Bitartrate60 in 1 BOTTLETABLET, EXTENDED RELEASE608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-396-60EA - Each47781-3969902edba-bce6-43a1-aec9-f2b896777b2c12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-396HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE [ALVOGEN INC.]5Current NDC, Legacy NDC, 1 package rows20240612_f7b55d14-0980-b680-8ceb-7489ff65455e.zip

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
Hydrocodone BitartrateHYDROCODONE BITARTRATEAlvogen Inc.f7b55d14-0980-b680-8ceb-7489ff65455e2025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208269
application number: ANDA208269
ndc (product): 47781-396

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1595764HYDROcodone bitartrate 100 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSNf7b55d14-0980-b680-8ceb-7489ff65455e8
1595770HYDROcodone bitartrate 120 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSNf7b55d14-0980-b680-8ceb-7489ff65455e8
1595730HYDROcodone bitartrate 20 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSNf7b55d14-0980-b680-8ceb-7489ff65455e8
1595740HYDROcodone bitartrate 30 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSNf7b55d14-0980-b680-8ceb-7489ff65455e8
1595746HYDROcodone bitartrate 40 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSNf7b55d14-0980-b680-8ceb-7489ff65455e8
1595752HYDROcodone bitartrate 60 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSNf7b55d14-0980-b680-8ceb-7489ff65455e8
1595758HYDROcodone bitartrate 80 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSNf7b55d14-0980-b680-8ceb-7489ff65455e8
1595764Abuse-Deterrent 24 HR hydrocodone bitartrate 100 MG Extended Release Oral TabletSCDf7b55d14-0980-b680-8ceb-7489ff65455e8
1595770Abuse-Deterrent 24 HR hydrocodone bitartrate 120 MG Extended Release Oral TabletSCDf7b55d14-0980-b680-8ceb-7489ff65455e8
1595730Abuse-Deterrent 24 HR hydrocodone bitartrate 20 MG Extended Release Oral TabletSCDf7b55d14-0980-b680-8ceb-7489ff65455e8
1595740Abuse-Deterrent 24 HR hydrocodone bitartrate 30 MG Extended Release Oral TabletSCDf7b55d14-0980-b680-8ceb-7489ff65455e8
1595746Abuse-Deterrent 24 HR hydrocodone bitartrate 40 MG Extended Release Oral TabletSCDf7b55d14-0980-b680-8ceb-7489ff65455e8
1595752Abuse-Deterrent 24 HR hydrocodone bitartrate 60 MG Extended Release Oral TabletSCDf7b55d14-0980-b680-8ceb-7489ff65455e8
1595758Abuse-Deterrent 24 HR hydrocodone bitartrate 80 MG Extended Release Oral TabletSCDf7b55d14-0980-b680-8ceb-7489ff65455e8
1595764hydrocodone bitartrate 100 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSYf7b55d14-0980-b680-8ceb-7489ff65455e8
1595770hydrocodone bitartrate 120 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSYf7b55d14-0980-b680-8ceb-7489ff65455e8
1595730hydrocodone bitartrate 20 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSYf7b55d14-0980-b680-8ceb-7489ff65455e8
1595740hydrocodone bitartrate 30 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSYf7b55d14-0980-b680-8ceb-7489ff65455e8
1595746hydrocodone bitartrate 40 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSYf7b55d14-0980-b680-8ceb-7489ff65455e8
1595752hydrocodone bitartrate 60 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSYf7b55d14-0980-b680-8ceb-7489ff65455e8
1595758hydrocodone bitartrate 80 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSYf7b55d14-0980-b680-8ceb-7489ff65455e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-396-604778103966060 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-396-60) 2021-03-030000-00-00NoNoCurrent