Oxycodone Hydrochloride

Product NDC
71930-023
11-digit product format
719300023
Labeler code
71930
Product ID
71930-023_353e35c4-e3fa-46d0-8497-8872b8c53c39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Eywa Pharma Inc
Application
ANDA209897
Marketing category
ANDA
Marketing start
2018-06-01
Substance
OXYCODONE HYDROCHLORIDE
Active strength
20 mg/mL
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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209897-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209897-001AA

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-063f01610625f2…
2019-09-15 20:21 UTC2019-09A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209897-001OXYCODONE HYDROCHLORIDE100MG/5MLSOLUTION / ORALAA2017-09-06cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209897-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209897-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209897-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209897-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209897-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209897-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209897-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209897-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209897-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209897-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209897-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209897-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209897-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209897-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209897-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209897-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209897-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209897-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209897-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209897-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209897-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A209897-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209897-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209897-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209897-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A209897-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209897-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209897-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209897-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209897-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209897-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209897-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209897-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209897-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209897-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209897-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209897-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209897-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209897-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209897-001AA1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Oxycodone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C1ENJ2TE6CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049615Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c801963d-f54d-4ed5-82c4-8b278528d3dcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
b8cd3792-f010-440e-ac63-7713119fde04Product name920220110
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
ac683e31-73f8-f1cd-ff51-87d7b0d20ab3Product name920190611
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
b7a189a6-82e9-f884-a16b-8cdc7e7d1556Product name620170913
5da64f4c-1e90-423d-af7a-5a52bb3e823eProduct name420170726
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
334cd9e0-ccc1-4fe7-b3a9-7d5942867ee6Product name120170628
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778Product name120161103
68d3ff71-7803-4cf4-ba84-71ce4712df22Product name120160620
07e5b999-fda7-79c9-8f77-8380537ade79Product name420160517
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
7fa873c5-fb27-7119-0a05-634ad477dea7Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product 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
71930-023-30Oxycodone Hydrochloride30 mL in 1 BOTTLESOLUTION308
71930-023-30Oxycodone Hydrochloride1 in 1 CARTONSOLUTION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71930-023-30ML - Milliliter71930-023e137ddc7-1274-438e-9fba-ee22ce20029312018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71930-023OXYCODONE HYDROCHLORIDE SOLUTION [EYWA PHARMA INC]7Current NDC, Legacy NDC, 2 package rows20240814_c801963d-f54d-4ed5-82c4-8b278528d3dc.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
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEEywa Pharma Incc801963d-f54d-4ed5-82c4-8b278528d3dc2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209897
application number: ANDA209897
ndc (product): 71930-023

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049615oxyCODONE HCl 20 MG in 1 mL Concentrate for Oral SolutionPSNc801963d-f54d-4ed5-82c4-8b278528d3dc8
1049615oxycodone hydrochloride 20 MG/ML Oral SolutionSCDc801963d-f54d-4ed5-82c4-8b278528d3dc8
1049615oxycodone hydrochloride 20 MG per 1 ML Concentrate for Oral SolutionSYc801963d-f54d-4ed5-82c4-8b278528d3dc8
1049615oxyCODONE HCl 20 MG in 1 mL Concentrate for Oral SolutionPSN1218495c-973c-4b9b-b2c0-48aa241ae6c92
1049615oxycodone hydrochloride 20 MG/ML Oral SolutionSCD1218495c-973c-4b9b-b2c0-48aa241ae6c92
1049615oxycodone hydrochloride 20 MG per 1 ML Concentrate for Oral SolutionSY1218495c-973c-4b9b-b2c0-48aa241ae6c92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71930-023-30719300023301 BOTTLE in 1 CARTON (71930-023-30) / 30 mL in 1 BOTTLE1 bottle2018-06-010000-00-00NoNoCurrent