Home NDC 13107-261-58 Oxycodone Hydrochloride Oral Solution
Product NDC 13107-261
Requested package NDC 13107-261-58
11-digit product format 131070261
Labeler code 13107
Product ID 13107-261_b0905edb-577e-4e2e-ab2f-c7f5c673b0e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxycodone Hydrochloride Oral Solution
Dosage form SOLUTION
Route ORAL
Labeler Aurolife Pharma, LLC
Application ANDA212429
Marketing category ANDA
Marketing start 2020-01-27
Substance OXYCODONE HYDROCHLORIDE
Active strength 5 mg/5mL
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212429-001 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2020-01-27 A212429-002 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2020-01-27
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 2 · 74 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 2026-02-19 14:30 UTC 2026-02 A212429-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2020-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212429-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2020-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212429-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2020-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212429-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2020-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212429-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2020-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212429-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2020-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212429-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2020-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212429-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2020-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212429-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2020-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212429-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2020-01-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212429-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2020-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212429-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2020-01-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212429-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2020-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212429-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2020-01-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212429-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2020-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212429-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2020-01-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212429-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2020-01-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212429-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2020-01-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212429-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2020-01-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212429-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2020-01-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212429-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2020-01-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212429-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2020-01-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212429-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2020-01-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212429-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2020-01-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212429-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2020-01-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212429-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2020-01-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212429-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2020-01-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212429-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2020-01-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212429-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2020-01-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212429-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2020-01-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212429-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2020-01-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212429-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2020-01-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212429-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2020-01-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A212429-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2020-01-27 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212429-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2020-01-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A212429-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2020-01-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212429-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2020-01-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A212429-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2020-01-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212429-001 OXYCODONE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2020-01-27 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212429-002 OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION / ORAL 2020-01-27 87673890dc5c…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Oxycodone Hydrochloride Oral Solution
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYCODONE HYDROCHLORIDE 5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C1ENJ2TE6C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049604 Internal RxNorm lookup 1049615 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 13107-261-58 Oxycodone Hydrochloride Oral Solution 500 mL in 1 BOTTLE SOLUTION 500 3 13107-261-58 Oxycodone Hydrochloride Oral Solution 1 in 1 CARTON SOLUTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13107-261 OXYCODONE HYDROCHLORIDE ORAL SOLUTION SOLUTION [AUROLIFE PHARMA, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20240802_0b3fa92e-8351-4401-860d-4bba8a7155e6.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# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 13107-261-58 13107026158 1 BOTTLE in 1 CARTON (13107-261-58) / 500 mL in 1 BOTTLE 1 bottle 2020-01-27 0000-00-00 No No Current