FDA.reportPublic FDA data

Hydrocodone Bitartrate

Product NDC
47781-410
Requested package NDC
47781-410-60
11-digit product format
477810410
Labeler code
47781
Product ID
47781-410_3bdd85f7-51e5-bd1a-ad5c-f23a7bf0ea7c
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
15 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 44.

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 · 240 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A206986-001HYDROCODONE BITARTRATE10MGCAPSULE, EXTENDED RELEASE / ORALRS2020-01-21c2088c7a36db…
2026-10-15 13:18:302026-09A206986-002HYDROCODONE BITARTRATE15MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21c2088c7a36db…
2026-10-15 13:18:302026-09A206986-003HYDROCODONE BITARTRATE20MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21c2088c7a36db…
2026-10-15 13:18:302026-09A206986-004HYDROCODONE BITARTRATE30MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21c2088c7a36db…
2026-10-15 13:18:302026-09A206986-005HYDROCODONE BITARTRATE40MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21c2088c7a36db…
2026-10-15 13:18:302026-09A206986-006HYDROCODONE BITARTRATE50MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21c2088c7a36db…
2026-09-14 22:38:342026-08A206986-001HYDROCODONE BITARTRATE10MGCAPSULE, EXTENDED RELEASE / ORALRS2020-01-2184e616aacf4f…
2026-09-14 22:38:342026-08A206986-002HYDROCODONE BITARTRATE15MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-2184e616aacf4f…
2026-09-14 22:38:342026-08A206986-003HYDROCODONE BITARTRATE20MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-2184e616aacf4f…
2026-09-14 22:38:342026-08A206986-004HYDROCODONE BITARTRATE30MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-2184e616aacf4f…
2026-09-14 22:38:342026-08A206986-005HYDROCODONE BITARTRATE40MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-2184e616aacf4f…
2026-09-14 22:38:342026-08A206986-006HYDROCODONE BITARTRATE50MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-2184e616aacf4f…
2026-08-18 06:07:402026-07A206986-001HYDROCODONE BITARTRATE10MGCAPSULE, EXTENDED RELEASE / ORALRS2020-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07A206986-002HYDROCODONE BITARTRATE15MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07A206986-003HYDROCODONE BITARTRATE20MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07A206986-004HYDROCODONE BITARTRATE30MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07A206986-005HYDROCODONE BITARTRATE40MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07A206986-006HYDROCODONE BITARTRATE50MGCAPSULE, EXTENDED RELEASE / ORAL2020-01-21caaa826d4ba7…
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…

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…

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
Hydrocodone Bitartrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCODONE BITARTRATE15 mg/1

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
47781-410-60Hydrocodone Bitartrate60 in 1 BOTTLECAPSULE, EXTENDED RELEASE609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-410-60EA - Each47781-4102684450d-b6c0-4dd4-bf7b-4a0f49bce50112020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-410HYDROCODONE BITARTRATE CAPSULE, EXTENDED RELEASE [ALVOGEN INC.]6Current NDC, Legacy NDC, 1 package rows20241121_a7b8ea07-e926-f0a5-c20d-92f23ed350d0.zip

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
47781-410-604778104106060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47781-410-60) 2020-01-210000-00-00NoNoCurrent