FDA.reportPublic FDA data

OXYCODONE AND ACETAMINOPHEN

Product NDC
10544-287
11-digit product format
105440287
Labeler code
10544
Product ID
10544-287_a2968165-848e-4000-9cad-c71e251a07bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone hydrochloride and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA087463
Marketing category
ANDA
Marketing start
2009-12-08
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
5 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-287-062019-10-21C16284748780-1956f9ecf-d21b-621f-e053-dbdaa90a74adOxycodone and Acetaminophen Tablets USP 5 mg*/325 mg, 7.5 mg*/325 mg, 7.5 mg*/500 mg and 10 mg*/325 mg CII Rx only
10544-287-152019-10-21C16284748780-1956f9ecf-d21b-621f-e053-dbdaa90a74adOxycodone and Acetaminophen Tablets USP 5 mg*/325 mg, 7.5 mg*/325 mg, 7.5 mg*/500 mg and 10 mg*/325 mg CII Rx only
10544-287-202019-10-21C16284748780-1956f9ecf-d21b-621f-e053-dbdaa90a74adOxycodone and Acetaminophen Tablets USP 5 mg*/325 mg, 7.5 mg*/325 mg, 7.5 mg*/500 mg and 10 mg*/325 mg CII Rx only
10544-287-302019-10-21C16284748780-1956f9ecf-d21b-621f-e053-dbdaa90a74adOxycodone and Acetaminophen Tablets USP 5 mg*/325 mg, 7.5 mg*/325 mg, 7.5 mg*/500 mg and 10 mg*/325 mg CII Rx only
10544-287-502019-10-21C16284748780-1956f9ecf-d21b-621f-e053-dbdaa90a74adOxycodone and Acetaminophen Tablets USP 5 mg*/325 mg, 7.5 mg*/325 mg, 7.5 mg*/500 mg and 10 mg*/325 mg CII Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-287-06OXYCODONE AND ACETAMINOPHEN6 in 1 BOTTLETABLET63
10544-287-15OXYCODONE AND ACETAMINOPHEN15 in 1 BOTTLETABLET153
10544-287-20OXYCODONE AND ACETAMINOPHEN20 in 1 BOTTLETABLET203
10544-287-30OXYCODONE AND ACETAMINOPHEN30 in 1 BOTTLETABLET303
10544-287-50OXYCODONE AND ACETAMINOPHEN50 in 1 BOTTLETABLET503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-287-06EA - Each10544-2879978255a-1823-49f5-aa90-f6e3d4b9b85d12015-10-02
10544-287-15EA - Each10544-287bbe78c3e-9ca5-4a77-a3af-872300f0713612015-10-02
10544-287-20EA - Each10544-287cf1d8b27-0342-463b-ab4a-022d5978082612015-10-02
10544-287-30EA - Each10544-28790253d8f-2e1f-40cb-aef0-6f735ab9dd2612015-10-02
10544-287-50EA - Each10544-2878196ce83-a6c2-482e-b23b-6478bb9e3cf912015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [BLENHEIM PHARMACAL, INC.]3
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [BLENHEIM PHARMACAL, INC.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [BLENHEIM PHARMACAL, INC.]3
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [BLENHEIM PHARMACAL, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [BLENHEIM PHARMACAL, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [BLENHEIM PHARMACAL, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [BLENHEIM PHARMACAL, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [BLENHEIM PHARMACAL, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [BLENHEIM PHARMACAL, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [BLENHEIM PHARMACAL, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-287OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET [BLENHEIM PHARMACAL, INC.]3Legacy NDC, 5 package rows20100826_60d2b60f-cbc1-4716-9c2a-ffc8292e3c85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049221oxyCODONE 5 MG / acetaminophen 325 MG Oral TabletPSN60d2b60f-cbc1-4716-9c2a-ffc8292e3c853
1049221acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral TabletSCD60d2b60f-cbc1-4716-9c2a-ffc8292e3c853
1049221APAP 325 MG / oxycodone hydrochloride 5 MG Oral TabletSY60d2b60f-cbc1-4716-9c2a-ffc8292e3c853

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-287-06105440287066 in 1 BOTTLEHistorical
10544-287-151054402871515 in 1 BOTTLEHistorical
10544-287-201054402872020 in 1 BOTTLEHistorical
10544-287-301054402873030 in 1 BOTTLEHistorical
10544-287-501054402875050 in 1 BOTTLEHistorical