Oxycodone Hydrochloride

Product NDC
31722-918
11-digit product format
317220918
Labeler code
31722
Product ID
31722-918_a506a2bf-6041-4ed7-bf7c-ffe50b1b3c2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals Inc
Application
ANDA207418
Marketing category
ANDA
Marketing start
2017-08-08
Substance
OXYCODONE HYDROCHLORIDE
Active strength
30 mg/1
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC1ENJ2TE6C
Rxcui1049611, 1049618, 1049621, 1049683, 1049686

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
31722-918-01Oxycodone Hydrochloride100 in 1 BOTTLETABLET1007
31722-918-05Oxycodone Hydrochloride500 in 1 BOTTLETABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-918-01EA - Each31722-918f693b04d-1b5b-4aa8-b0da-2ce992a492f312017-10-13
31722-918-05EA - Each31722-9182614f29a-9672-4d86-a751-a6d291f0c5c412017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-918OXYCODONE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC]6Current NDC, Legacy NDC, 2 package rows20210720_01db4606-d49c-4b10-a78a-1cf41880a9fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049618oxyCODONE HCl 30 MG Oral TabletPSNb6d0f446-cc77-443a-bcee-d5504ab3e5c9104
1049618oxyCODONE HCl 30 MG Oral TabletPSN35030c55-47e6-44cb-9d96-0c3cd5d0c238104
1049618oxycodone hydrochloride 30 MG Oral TabletSCDb6d0f446-cc77-443a-bcee-d5504ab3e5c9104
1049618oxycodone hydrochloride 30 MG Oral TabletSCD35030c55-47e6-44cb-9d96-0c3cd5d0c238104
1049618oxyCODONE HCl 30 MG Oral TabletPSNff7f1268-ddb7-4742-beee-8b12966fe8f9102
1049618oxyCODONE HCl 30 MG Oral TabletPSN27124cdf-a3e8-474c-9c1e-6fa48f6ddc05102
1049618oxycodone hydrochloride 30 MG Oral TabletSCDff7f1268-ddb7-4742-beee-8b12966fe8f9102
1049618oxycodone hydrochloride 30 MG Oral TabletSCD27124cdf-a3e8-474c-9c1e-6fa48f6ddc05102
1049683oxyCODONE HCl 10 MG Oral TabletPSN01db4606-d49c-4b10-a78a-1cf41880a9fb7
1049611oxyCODONE HCl 15 MG Oral TabletPSN01db4606-d49c-4b10-a78a-1cf41880a9fb7
1049686oxyCODONE HCl 20 MG Oral TabletPSN01db4606-d49c-4b10-a78a-1cf41880a9fb7
1049618oxyCODONE HCl 30 MG Oral TabletPSN01db4606-d49c-4b10-a78a-1cf41880a9fb7
1049621oxyCODONE HCl 5 MG Oral TabletPSN01db4606-d49c-4b10-a78a-1cf41880a9fb7
1049683oxycodone hydrochloride 10 MG Oral TabletSCD01db4606-d49c-4b10-a78a-1cf41880a9fb7
1049611oxycodone hydrochloride 15 MG Oral TabletSCD01db4606-d49c-4b10-a78a-1cf41880a9fb7
1049686oxycodone hydrochloride 20 MG Oral TabletSCD01db4606-d49c-4b10-a78a-1cf41880a9fb7
1049618oxycodone hydrochloride 30 MG Oral TabletSCD01db4606-d49c-4b10-a78a-1cf41880a9fb7
1049621oxycodone hydrochloride 5 MG Oral TabletSCD01db4606-d49c-4b10-a78a-1cf41880a9fb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-918-0131722091801100 TABLET in 1 BOTTLE (31722-918-01) 100 tablet2017-08-080000-00-00NoNoCurrent
31722-918-0531722091805500 TABLET in 1 BOTTLE (31722-918-05) 500 tablet2017-08-080000-00-00NoNoCurrent