FDA.reportPublic FDA data

Hydrocodone Bitartrate

Product NDC
47781-409
11-digit product format
477810409
Labeler code
47781
Product ID
47781-409_efb4a6cd-a407-a935-70b9-6ab1074ca819
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Alvogen Inc.
Application
ANDA206986
Marketing category
ANDA
Marketing start
2020-01-21
Substance
HYDROCODONE BITARTRATE
Active strength
10 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206986-001HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE10MGCAPSULE, EXTENDED RELEASE / ORALRS2020-01-21
A206986-002HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE15MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21
A206986-003HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE20MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21
A206986-004HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE30MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21
A206986-005HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE40MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21
A206986-006HYDROCODONE BITARTRATEHYDROCODONE BITARTRATE50MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21

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 · 222 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206986-001HYDROCODONE BITARTRATE10MGCAPSULE, EXTENDED RELEASE / ORALRS2020-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206986-002HYDROCODONE BITARTRATE15MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206986-003HYDROCODONE BITARTRATE20MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206986-004HYDROCODONE BITARTRATE30MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206986-005HYDROCODONE BITARTRATE40MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206986-006HYDROCODONE BITARTRATE50MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206986-001HYDROCODONE BITARTRATE10MGCAPSULE, EXTENDED RELEASE / ORALRS2020-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206986-002HYDROCODONE BITARTRATE15MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206986-003HYDROCODONE BITARTRATE20MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206986-004HYDROCODONE BITARTRATE30MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206986-005HYDROCODONE BITARTRATE40MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206986-006HYDROCODONE BITARTRATE50MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206986-001HYDROCODONE BITARTRATE10MGCAPSULE, EXTENDED RELEASE / ORALRS2020-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206986-002HYDROCODONE BITARTRATE15MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206986-003HYDROCODONE BITARTRATE20MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206986-004HYDROCODONE BITARTRATE30MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206986-005HYDROCODONE BITARTRATE40MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206986-006HYDROCODONE BITARTRATE50MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206986-001HYDROCODONE BITARTRATE10MGCAPSULE, EXTENDED RELEASE / ORALRS2020-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206986-002HYDROCODONE BITARTRATE15MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206986-003HYDROCODONE BITARTRATE20MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206986-004HYDROCODONE BITARTRATE30MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206986-005HYDROCODONE BITARTRATE40MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206986-006HYDROCODONE BITARTRATE50MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206986-001HYDROCODONE BITARTRATE10MGCAPSULE, EXTENDED RELEASE / ORALRS2020-01-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206986-002HYDROCODONE BITARTRATE15MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206986-003HYDROCODONE BITARTRATE20MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206986-004HYDROCODONE BITARTRATE30MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206986-005HYDROCODONE BITARTRATE40MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206986-006HYDROCODONE BITARTRATE50MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206986-001HYDROCODONE BITARTRATE10MGCAPSULE, EXTENDED RELEASE / ORALRS2020-01-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206986-002HYDROCODONE BITARTRATE15MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206986-003HYDROCODONE BITARTRATE20MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206986-004HYDROCODONE BITARTRATE30MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206986-005HYDROCODONE BITARTRATE40MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206986-006HYDROCODONE BITARTRATE50MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206986-001HYDROCODONE BITARTRATE10MGCAPSULE, EXTENDED RELEASE / ORALRS2020-01-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206986-002HYDROCODONE BITARTRATE15MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206986-003HYDROCODONE BITARTRATE20MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206986-004HYDROCODONE BITARTRATE30MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-212680178bc6a6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206986-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206986-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206986-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206986-004AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206986-005AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206986-006AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A206986-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A206986-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A206986-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A206986-004AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A206986-005AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A206986-006AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206986-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A206986-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A206986-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A206986-004AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A206986-005AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A206986-006AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206986-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A206986-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A206986-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A206986-004AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A206986-005AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A206986-006AB1c0c555d07b60…

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocodone Bitartrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCODONE BITARTRATE10 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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1860491Internal RxNorm lookup
1860493Internal RxNorm lookup
1860495Internal RxNorm lookup
1860497Internal RxNorm lookup
1860499Internal RxNorm lookup
1860501Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a7b8ea07-e926-f0a5-c20d-92f23ed350d0Available 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
47781-409-60Hydrocodone Bitartrate60 in 1 BOTTLECAPSULE, EXTENDED RELEASE609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-409-60EA - Each47781-409a89664c0-21d4-4df1-968e-2b8481035e2a12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-409HYDROCODONE BITARTRATE CAPSULE, EXTENDED RELEASE [ALVOGEN INC.]6Current NDC, Legacy NDC, 1 package rows20241121_a7b8ea07-e926-f0a5-c20d-92f23ed350d0.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.a7b8ea07-e926-f0a5-c20d-92f23ed350d02023-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206986
application number: ANDA206986
ndc (product): 47781-409

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1860491HYDROcodone bitartrate 10 MG 12HR Extended Release Oral CapsulePSNa7b8ea07-e926-f0a5-c20d-92f23ed350d09
1860493HYDROcodone bitartrate 15 MG 12HR Extended Release Oral CapsulePSNa7b8ea07-e926-f0a5-c20d-92f23ed350d09
1860495HYDROcodone bitartrate 20 MG 12HR Extended Release Oral CapsulePSNa7b8ea07-e926-f0a5-c20d-92f23ed350d09
1860497HYDROcodone bitartrate 30 MG 12HR Extended Release Oral CapsulePSNa7b8ea07-e926-f0a5-c20d-92f23ed350d09
1860499HYDROcodone bitartrate 40 MG 12HR Extended Release Oral CapsulePSNa7b8ea07-e926-f0a5-c20d-92f23ed350d09
1860501HYDROcodone bitartrate 50 MG 12HR Extended Release Oral CapsulePSNa7b8ea07-e926-f0a5-c20d-92f23ed350d09
186049112 HR hydrocodone bitartrate 10 MG Extended Release Oral CapsuleSCDa7b8ea07-e926-f0a5-c20d-92f23ed350d09
186049312 HR hydrocodone bitartrate 15 MG Extended Release Oral CapsuleSCDa7b8ea07-e926-f0a5-c20d-92f23ed350d09
186049512 HR hydrocodone bitartrate 20 MG Extended Release Oral CapsuleSCDa7b8ea07-e926-f0a5-c20d-92f23ed350d09
186049712 HR hydrocodone bitartrate 30 MG Extended Release Oral CapsuleSCDa7b8ea07-e926-f0a5-c20d-92f23ed350d09
186049912 HR hydrocodone bitartrate 40 MG Extended Release Oral CapsuleSCDa7b8ea07-e926-f0a5-c20d-92f23ed350d09
186050112 HR hydrocodone bitartrate 50 MG Extended Release Oral CapsuleSCDa7b8ea07-e926-f0a5-c20d-92f23ed350d09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-409-604778104096060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47781-409-60) 2020-01-210000-00-00NoNoCurrent