Home NDC 47781-393 Hydrocodone Bitartrate
Product NDC 47781-393
11-digit product format 477810393
Labeler code 47781
Product ID 47781-393_c0f6333c-1d3f-3519-b157-cf817bd5c81d
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 30 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 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208269-001 HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE 20MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 A208269-002 HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE 30MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 A208269-003 HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE 40MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 A208269-004 HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE 60MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 A208269-005 HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE 80MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 A208269-006 HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 A208269-007 HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE 120MG TABLET, EXTENDED RELEASE / ORAL 2021-03-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
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 7 · 259 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A208269-001 HYDROCODONE BITARTRATE 20MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 A208269-002 HYDROCODONE BITARTRATE 30MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 A208269-003 HYDROCODONE BITARTRATE 40MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 A208269-004 HYDROCODONE BITARTRATE 60MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 A208269-005 HYDROCODONE BITARTRATE 80MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 A208269-006 HYDROCODONE BITARTRATE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 A208269-007 HYDROCODONE BITARTRATE 120MG TABLET, EXTENDED RELEASE / ORAL 2021-03-01 c2088c7a36db…2026-09-14 22:38:34 2026-08 A208269-001 HYDROCODONE BITARTRATE 20MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208269-002 HYDROCODONE BITARTRATE 30MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208269-003 HYDROCODONE BITARTRATE 40MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208269-004 HYDROCODONE BITARTRATE 60MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208269-005 HYDROCODONE BITARTRATE 80MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208269-006 HYDROCODONE BITARTRATE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208269-007 HYDROCODONE BITARTRATE 120MG TABLET, EXTENDED RELEASE / ORAL 2021-03-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208269-001 HYDROCODONE BITARTRATE 20MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208269-002 HYDROCODONE BITARTRATE 30MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208269-003 HYDROCODONE BITARTRATE 40MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208269-004 HYDROCODONE BITARTRATE 60MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208269-005 HYDROCODONE BITARTRATE 80MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208269-006 HYDROCODONE BITARTRATE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208269-007 HYDROCODONE BITARTRATE 120MG TABLET, EXTENDED RELEASE / ORAL 2021-03-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208269-001 HYDROCODONE BITARTRATE 20MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208269-002 HYDROCODONE BITARTRATE 30MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208269-003 HYDROCODONE BITARTRATE 40MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208269-004 HYDROCODONE BITARTRATE 60MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208269-005 HYDROCODONE BITARTRATE 80MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208269-006 HYDROCODONE BITARTRATE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208269-007 HYDROCODONE BITARTRATE 120MG TABLET, EXTENDED RELEASE / ORAL 2021-03-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208269-001 HYDROCODONE BITARTRATE 20MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208269-002 HYDROCODONE BITARTRATE 30MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208269-003 HYDROCODONE BITARTRATE 40MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208269-004 HYDROCODONE BITARTRATE 60MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208269-005 HYDROCODONE BITARTRATE 80MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208269-006 HYDROCODONE BITARTRATE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208269-007 HYDROCODONE BITARTRATE 120MG TABLET, EXTENDED RELEASE / ORAL 2021-03-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208269-001 HYDROCODONE BITARTRATE 20MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208269-002 HYDROCODONE BITARTRATE 30MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208269-003 HYDROCODONE BITARTRATE 40MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208269-004 HYDROCODONE BITARTRATE 60MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208269-005 HYDROCODONE BITARTRATE 80MG TABLET, EXTENDED RELEASE / ORAL AB 2021-03-01 6a471c1ec25d…
Observed Orange Book normalized TE history# Normalized TE history page 7 of 7 · 249 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208269-005 AB 1 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208269-006 AB 1 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208269-007 AB 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208269-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208269-002 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208269-003 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208269-004 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208269-005 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208269-006 AB 1 a50c72e98297…
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 Ingredient Strength HYDROCODONE BITARTRATE 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination NO70W886KK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 7 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1595730 Internal RxNorm lookup 1595740 Internal RxNorm lookup 1595746 Internal RxNorm lookup 1595752 Internal RxNorm lookup 1595758 Internal RxNorm lookup 1595764 Internal RxNorm lookup 1595770 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 47781-393-60 Hydrocodone Bitartrate 60 in 1 BOTTLE TABLET, EXTENDED RELEASE 60 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47781-393 HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE [ALVOGEN INC.] 5 Current NDC, Legacy NDC, 1 package rows 20240612_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.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1595764 HYDROcodone bitartrate 100 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent PSN f7b55d14-0980-b680-8ceb-7489ff65455e 8 1595770 HYDROcodone bitartrate 120 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent PSN f7b55d14-0980-b680-8ceb-7489ff65455e 8 1595730 HYDROcodone bitartrate 20 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent PSN f7b55d14-0980-b680-8ceb-7489ff65455e 8 1595740 HYDROcodone bitartrate 30 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent PSN f7b55d14-0980-b680-8ceb-7489ff65455e 8 1595746 HYDROcodone bitartrate 40 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent PSN f7b55d14-0980-b680-8ceb-7489ff65455e 8 1595752 HYDROcodone bitartrate 60 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent PSN f7b55d14-0980-b680-8ceb-7489ff65455e 8 1595758 HYDROcodone bitartrate 80 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent PSN f7b55d14-0980-b680-8ceb-7489ff65455e 8 1595764 Abuse-Deterrent 24 HR hydrocodone bitartrate 100 MG Extended Release Oral Tablet SCD f7b55d14-0980-b680-8ceb-7489ff65455e 8 1595770 Abuse-Deterrent 24 HR hydrocodone bitartrate 120 MG Extended Release Oral Tablet SCD f7b55d14-0980-b680-8ceb-7489ff65455e 8 1595730 Abuse-Deterrent 24 HR hydrocodone bitartrate 20 MG Extended Release Oral Tablet SCD f7b55d14-0980-b680-8ceb-7489ff65455e 8 1595740 Abuse-Deterrent 24 HR hydrocodone bitartrate 30 MG Extended Release Oral Tablet SCD f7b55d14-0980-b680-8ceb-7489ff65455e 8 1595746 Abuse-Deterrent 24 HR hydrocodone bitartrate 40 MG Extended Release Oral Tablet SCD f7b55d14-0980-b680-8ceb-7489ff65455e 8 1595752 Abuse-Deterrent 24 HR hydrocodone bitartrate 60 MG Extended Release Oral Tablet SCD f7b55d14-0980-b680-8ceb-7489ff65455e 8 1595758 Abuse-Deterrent 24 HR hydrocodone bitartrate 80 MG Extended Release Oral Tablet SCD f7b55d14-0980-b680-8ceb-7489ff65455e 8 1595764 hydrocodone bitartrate 100 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent SY f7b55d14-0980-b680-8ceb-7489ff65455e 8 1595770 hydrocodone bitartrate 120 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent SY f7b55d14-0980-b680-8ceb-7489ff65455e 8 1595730 hydrocodone bitartrate 20 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent SY f7b55d14-0980-b680-8ceb-7489ff65455e 8 1595740 hydrocodone bitartrate 30 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent SY f7b55d14-0980-b680-8ceb-7489ff65455e 8 1595746 hydrocodone bitartrate 40 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent SY f7b55d14-0980-b680-8ceb-7489ff65455e 8 1595752 hydrocodone bitartrate 60 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent SY f7b55d14-0980-b680-8ceb-7489ff65455e 8 1595758 hydrocodone bitartrate 80 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent SY f7b55d14-0980-b680-8ceb-7489ff65455e 8
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 47781-393-60 47781039360 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-393-60) 2021-03-03 0000-00-00 No No Current