FDA.reportPublic FDA data

Hydrocodone Bitartrate And Acetaminophen

Product NDC
66336-442
11-digit product format
663360442
Labeler code
66336
Product ID
66336-442_c2b43b77-8ebb-4559-aaae-2d17741bce3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate And Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA089971
Marketing category
ANDA
Marketing start
1988-12-02
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
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
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
377068df-225f-7318-a910-a1987cdfa361Product name320170608
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
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66336-442-062019-11-27C16284748780-19855d018-eebe-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-442-102019-11-27C16284748780-19855d018-eebe-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-442-122019-11-27C16284748780-19855d018-eebe-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-442-142019-11-27C16284748780-19855d018-eebe-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-442-152019-11-27C16284748780-19855d018-eebe-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-442-162019-11-27C16284748780-19855d018-eebe-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-442-202019-11-27C16284748780-19855d018-eebe-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-442-242019-11-27C16284748780-19855d018-eebe-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-442-302019-11-27C16284748780-19855d018-eebe-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-442-402019-11-27C16284748780-19855d018-eebe-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-442-442019-11-27C16284748780-19855d018-eebe-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-442-452019-11-27C16284748780-19855d018-eebe-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-442-602019-11-27C16284748780-19855d018-eebe-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-442-902019-11-27C16284748780-19855d018-eebe-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
66336-442-942019-11-27C16284748780-19855d018-eebe-cd31-e053-dbdaa90ab51aHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-442-06Hydrocodone Bitartrate And Acetaminophen6 in 1 BOTTLE, PLASTICTABLET62
66336-442-10Hydrocodone Bitartrate And Acetaminophen10 in 1 BOTTLE, PLASTICTABLET102
66336-442-12Hydrocodone Bitartrate And Acetaminophen12 in 1 BOTTLE, PLASTICTABLET122
66336-442-14Hydrocodone Bitartrate And Acetaminophen14 in 1 BOTTLE, PLASTICTABLET142
66336-442-15Hydrocodone Bitartrate And Acetaminophen15 in 1 BOTTLE, PLASTICTABLET152
66336-442-16Hydrocodone Bitartrate And Acetaminophen16 in 1 BOTTLE, PLASTICTABLET162
66336-442-20Hydrocodone Bitartrate And Acetaminophen20 in 1 BOTTLE, PLASTICTABLET202
66336-442-24Hydrocodone Bitartrate And Acetaminophen24 in 1 BOTTLE, PLASTICTABLET242
66336-442-30Hydrocodone Bitartrate And Acetaminophen30 in 1 BOTTLE, PLASTICTABLET302
66336-442-40Hydrocodone Bitartrate And Acetaminophen40 in 1 BOTTLE, PLASTICTABLET402
66336-442-44Hydrocodone Bitartrate And Acetaminophen4 in 1 BOTTLE, PLASTICTABLET42
66336-442-45Hydrocodone Bitartrate And Acetaminophen45 in 1 BOTTLE, PLASTICTABLET452
66336-442-60Hydrocodone Bitartrate And Acetaminophen60 in 1 BOTTLE, PLASTICTABLET602
66336-442-90Hydrocodone Bitartrate And Acetaminophen90 in 1 BOTTLE, PLASTICTABLET902
66336-442-94Hydrocodone Bitartrate And Acetaminophen120 in 1 BOTTLE, PLASTICTABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66336-442-06EA - Each66336-44260dc49ec-3ffc-4680-b3bf-2556236c8d1912012-07-24
66336-442-10EA - Each66336-4420ac61077-a8b9-40d3-89e8-ac1c2e29413512012-07-24
66336-442-12EA - Each66336-442cd602e17-8c2e-4296-9b37-29dc37adf00112012-07-24
66336-442-15EA - Each66336-44234b1b29c-aeaf-4216-9a48-442cd60df9f912012-07-24
66336-442-16EA - Each66336-44209e6241a-3d64-4f4e-a20b-5e74d915f79912012-07-24
66336-442-20EA - Each66336-44299174d8f-b75c-43b4-b3fb-f23c2e7a298512013-03-03
66336-442-24EA - Each66336-442dfe3b555-c2f4-4f58-a086-c4ee77a368de12012-07-24
66336-442-30EA - Each66336-44213e4be18-8d9b-4bb2-a99e-5980b59ccf8812012-07-24
66336-442-40EA - Each66336-44233920c89-528c-4b32-96dd-ccfca2a90bd312012-07-24
66336-442-60EA - Each66336-44248caa7be-ef2c-4dfb-81c7-daa70175afaf12012-07-24
66336-442-90EA - Each66336-442ec2f91d2-5d77-415f-b682-7091ef9109a212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.]2
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.]2
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-442HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 15 package rows20130820_1b733f85-dafb-4242-be8a-65540d956380.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856903HYDROcodone bitartrate 5 MG / acetaminophen 500 MG Oral TabletPSN1b733f85-dafb-4242-be8a-65540d9563802
856903acetaminophen 500 MG / hydrocodone bitartrate 5 MG Oral TabletSCD1b733f85-dafb-4242-be8a-65540d9563802
856903APAP 500 MG / hydrocodone bitartrate 5 MG Oral TabletSY1b733f85-dafb-4242-be8a-65540d9563802

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-442-06663360442066 in 1 BOTTLE, PLASTICHistorical
66336-442-106633604421010 in 1 BOTTLE, PLASTICHistorical
66336-442-126633604421212 in 1 BOTTLE, PLASTICHistorical
66336-442-146633604421414 in 1 BOTTLE, PLASTICHistorical
66336-442-156633604421515 in 1 BOTTLE, PLASTICHistorical
66336-442-166633604421616 in 1 BOTTLE, PLASTICHistorical
66336-442-206633604422020 in 1 BOTTLE, PLASTICHistorical
66336-442-246633604422424 in 1 BOTTLE, PLASTICHistorical
66336-442-306633604423030 in 1 BOTTLE, PLASTICHistorical
66336-442-406633604424040 in 1 BOTTLE, PLASTICHistorical
66336-442-44663360442444 in 1 BOTTLE, PLASTICHistorical
66336-442-456633604424545 in 1 BOTTLE, PLASTICHistorical
66336-442-606633604426060 in 1 BOTTLE, PLASTICHistorical
66336-442-906633604429090 in 1 BOTTLE, PLASTICHistorical
66336-442-9466336044294120 in 1 BOTTLE, PLASTICHistorical