FDA.reportPublic FDA data

Xodol

Product NDC
21695-773
11-digit product format
216950773
Labeler code
21695
Product ID
21695-773_3d6ce551-6a0a-4d40-8592-cd6d92d55913
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA040658
Marketing category
ANDA
Marketing start
2004-06-23
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
5 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CIII
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
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
7855f8e3-562e-4273-8b79-0059c07a71f7Product name120170901
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
a5244f9c-cd67-0e27-d63b-65fd7e584400Product name220170504
b654f2d9-ebeb-451d-96ee-22f583344623Product name120170424
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-773-302019-09-24C16284748780-1934fe258-4a1c-48b1-e053-8cdaa90a720aXodol
21695-773-602019-09-24C16284748780-1934fe258-4a1c-48b1-e053-8cdaa90a720aXodol
21695-773-722019-09-24C16284748780-1934fe258-4a1c-48b1-e053-8cdaa90a720aXodol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-773-30Xodol30 in 1 BOTTLETABLET302
21695-773-60Xodol60 in 1 BOTTLETABLET602
21695-773-72Xodol120 in 1 BOTTLETABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-773-30EA - Each21695-773615752c8-dabc-40de-9008-8718f56f7cd212012-07-24
21695-773-60EA - Each21695-77382c9e980-ef65-410f-9d48-e0363aefe5e712012-07-24
21695-773-72EA - Each21695-7730fc9fd51-2cf7-4f65-80f2-efe7c3fea64b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DXODOL (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP.]2
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKXODOL (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DXODOL (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP.]2
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7XODOL (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UXODOL (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKXODOL (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30XODOL (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EXODOL (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4XODOL (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJXODOL (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APXODOL (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-773XODOL (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) TABLET [REBEL DISTRIBUTORS CORP.]2Legacy NDC, 3 package rows20110601_ddfc14c4-6f0f-4f97-b49f-d516552d3c1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856980HYDROcodone bitartrate 10 MG / acetaminophen 300 MG Oral TabletPSNddfc14c4-6f0f-4f97-b49f-d516552d3c1f2
856987HYDROcodone bitartrate 5 MG / acetaminophen 300 MG Oral TabletPSNddfc14c4-6f0f-4f97-b49f-d516552d3c1f2
856992HYDROcodone bitartrate 7.5 MG / acetaminophen 300 MG Oral TabletPSNddfc14c4-6f0f-4f97-b49f-d516552d3c1f2
856984acetaminophen 300 MG / hydrocodone bitartrate 10 MG Oral Tablet [Xodol]SBDddfc14c4-6f0f-4f97-b49f-d516552d3c1f2
856991acetaminophen 300 MG / hydrocodone bitartrate 5 MG Oral Tablet [Xodol]SBDddfc14c4-6f0f-4f97-b49f-d516552d3c1f2
856996acetaminophen 300 MG / hydrocodone bitartrate 7.5 MG Oral Tablet [Xodol]SBDddfc14c4-6f0f-4f97-b49f-d516552d3c1f2
856980acetaminophen 300 MG / hydrocodone bitartrate 10 MG Oral TabletSCDddfc14c4-6f0f-4f97-b49f-d516552d3c1f2
856987acetaminophen 300 MG / hydrocodone bitartrate 5 MG Oral TabletSCDddfc14c4-6f0f-4f97-b49f-d516552d3c1f2
856992acetaminophen 300 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDddfc14c4-6f0f-4f97-b49f-d516552d3c1f2
856980APAP 300 MG / hydrocodone bitartrate 10 MG Oral TabletSYddfc14c4-6f0f-4f97-b49f-d516552d3c1f2
856984APAP 300 MG / Hydrocodone Bitartrate 10 MG Oral Tablet [Xodol]SYddfc14c4-6f0f-4f97-b49f-d516552d3c1f2
856987APAP 300 MG / hydrocodone bitartrate 5 MG Oral TabletSYddfc14c4-6f0f-4f97-b49f-d516552d3c1f2
856991APAP 300 MG / Hydrocodone Bitartrate 5 MG Oral Tablet [Xodol]SYddfc14c4-6f0f-4f97-b49f-d516552d3c1f2
856992APAP 300 MG / Hydrocodone Bitartrate 7.5 MG Oral TabletSYddfc14c4-6f0f-4f97-b49f-d516552d3c1f2
856996APAP 300 MG / Hydrocodone Bitartrate 7.5 MG Oral Tablet [Xodol]SYddfc14c4-6f0f-4f97-b49f-d516552d3c1f2
856984Xodol (APAP 300 MG / hydrocodone bitartrate 10 MG) Oral TabletSYddfc14c4-6f0f-4f97-b49f-d516552d3c1f2
856991Xodol (APAP 300 MG / hydrocodone bitartrate 5 MG) Oral TabletSYddfc14c4-6f0f-4f97-b49f-d516552d3c1f2
856996Xodol (APAP 300 MG / hydrocodone bitartrate 7.5 MG) Oral TabletSYddfc14c4-6f0f-4f97-b49f-d516552d3c1f2
856984Xodol 10/300 Oral TabletSYddfc14c4-6f0f-4f97-b49f-d516552d3c1f2
856991Xodol 5/300 Oral TabletSYddfc14c4-6f0f-4f97-b49f-d516552d3c1f2
856996Xodol 7.5/300 Oral TabletSYddfc14c4-6f0f-4f97-b49f-d516552d3c1f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-773-302169507733030 in 1 BOTTLEHistorical
21695-773-602169507736060 in 1 BOTTLEHistorical
21695-773-7221695077372120 in 1 BOTTLEHistorical