FDA.reportPublic FDA data

Oxycodone Hydrochloride

Product NDC
0406-8557
11-digit product format
004068557
Labeler code
0406
Product ID
0406-8557_d70b1a5c-a3b2-43d5-bb44-633ae8d73603
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA210758
Marketing category
ANDA
Marketing start
2018-04-30
Substance
OXYCODONE HYDROCHLORIDE
Active strength
100 mg/5mL
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210758-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-04-30
A210758-002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2018-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A210758-001AA
A210758-002AA

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210758-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-04-3084e616aacf4f…
2026-09-14 22:38:342026-08A210758-002OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2018-04-3084e616aacf4f…
2026-08-18 06:07:402026-07A210758-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07A210758-002OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2018-04-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210758-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210758-002OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2018-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210758-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210758-002OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2018-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A210758-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210758-002OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2018-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210758-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210758-002OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2018-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210758-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210758-002OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2018-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210758-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210758-002OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2018-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210758-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210758-002OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2018-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210758-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210758-002OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2018-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210758-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210758-002OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2018-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210758-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-04-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A210758-002OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2018-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210758-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-04-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210758-002OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2018-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210758-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-04-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210758-002OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2018-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210758-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-04-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210758-002OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2018-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210758-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-04-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210758-002OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2018-04-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210758-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-04-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210758-002OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2018-04-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210758-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-04-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210758-002OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2018-04-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210758-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-04-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210758-002OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2018-04-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210758-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2018-04-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210758-002OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2018-04-3074a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A210758-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A210758-002AA184e616aacf4f…
2026-08-18 06:07:402026-07A210758-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A210758-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210758-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210758-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210758-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210758-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210758-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210758-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210758-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210758-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210758-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210758-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210758-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210758-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210758-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210758-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210758-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210758-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210758-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210758-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210758-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210758-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210758-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210758-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210758-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210758-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210758-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210758-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210758-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210758-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210758-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210758-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210758-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210758-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210758-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210758-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210758-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210758-002AA174a2ff9319b5…

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
Oxycodone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE100 mg/5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
b8cd3792-f010-440e-ac63-7713119fde04Product name920220110
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
ac683e31-73f8-f1cd-ff51-87d7b0d20ab3Product name920190611
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
b7a189a6-82e9-f884-a16b-8cdc7e7d1556Product name620170913
5da64f4c-1e90-423d-af7a-5a52bb3e823eProduct name420170726
334cd9e0-ccc1-4fe7-b3a9-7d5942867ee6Product name120170628
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778Product name120161103
68d3ff71-7803-4cf4-ba84-71ce4712df22Product name120160620
07e5b999-fda7-79c9-8f77-8380537ade79Product name420160517
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
7fa873c5-fb27-7119-0a05-634ad477dea7Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
f46484d2-0de6-24f4-bf73-a8f2af6723efProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0406-8557-30Oxycodone Hydrochloride1 in 1 CARTONSOLUTION123
0406-8557-30Oxycodone Hydrochloride30 mL in 1 BOTTLE, PLASTICSOLUTION3023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-8557-30ML - Milliliter0406-85575aa1c7d6-4ade-48f6-9bf9-629c2f1343f112018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-8557OXYCODONE HYDROCHLORIDE SOLUTION [SPECGX LLC]21Current NDC, Legacy NDC, 2 package rows20240906_5451bcaa-0aca-4581-bcea-2f9c2a33b260.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049615oxyCODONE HCl 20 MG in 1 mL Concentrate for Oral SolutionPSN5451bcaa-0aca-4581-bcea-2f9c2a33b26023
1049604oxyCODONE HCl 5 MG in 5 mL Oral SolutionPSN5451bcaa-0aca-4581-bcea-2f9c2a33b26023
1049604oxycodone hydrochloride 1 MG/ML Oral SolutionSCD5451bcaa-0aca-4581-bcea-2f9c2a33b26023
1049615oxycodone hydrochloride 20 MG/ML Oral SolutionSCD5451bcaa-0aca-4581-bcea-2f9c2a33b26023
1049615oxycodone hydrochloride 20 MG per 1 ML Concentrate for Oral SolutionSY5451bcaa-0aca-4581-bcea-2f9c2a33b26023
1049604oxycodone hydrochloride 5 MG per 5 ML Oral SolutionSY5451bcaa-0aca-4581-bcea-2f9c2a33b26023

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0406-8557-30004068557301 BOTTLE, PLASTIC in 1 CARTON (0406-8557-30) / 30 mL in 1 BOTTLE, PLASTIC2018-04-300000-00-00NoNoCurrent