FDA.reportPublic FDA data

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC
12634-264
11-digit product format
126340264
Labeler code
12634
Product ID
12634-264_357d7f87-1694-2dc5-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocodone bitartrate and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA040099
Marketing category
ANDA
Marketing start
1997-06-25
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
CII
NDC exclude flag
No
Listing certified through
2019-12-31
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
12634-264-002020-01-31C16284748780-19d75b9d0-f106-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-402020-01-31C16284748780-19d75b9d0-f106-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-502020-01-31C16284748780-19d75b9d0-f106-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-572020-01-31C16284748780-19d75b9d0-f106-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-592020-01-31C16284748780-19d75b9d0-f106-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-612020-01-31C16284748780-19d75b9d0-f106-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-642020-01-31C16284748780-19d75b9d0-f106-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-652020-01-31C16284748780-19d75b9d0-f106-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-662020-01-31C16284748780-19d75b9d0-f106-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-712020-01-31C16284748780-19d75b9d0-f106-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-802020-01-31C16284748780-19d75b9d0-f106-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-822020-01-31C16284748780-19d75b9d0-f106-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-852020-01-31C16284748780-19d75b9d0-f106-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-912020-01-31C16284748780-19d75b9d0-f106-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-922020-01-31C16284748780-19d75b9d0-f106-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-942020-01-31C16284748780-19d75b9d0-f106-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-952020-01-31C16284748780-19d75b9d0-f106-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-962020-01-31C16284748780-19d75b9d0-f106-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-264-00HYDROCODONE BITARTRATE AND ACETAMINOPHEN10 in 1 BOTTLETABLET107
12634-264-40HYDROCODONE BITARTRATE AND ACETAMINOPHEN40 in 1 BOTTLE, PLASTICTABLET407
12634-264-50HYDROCODONE BITARTRATE AND ACETAMINOPHEN50 in 1 BOTTLE, PLASTICTABLET507
12634-264-57HYDROCODONE BITARTRATE AND ACETAMINOPHEN20 in 1 BLISTER PACKTABLET207
12634-264-59HYDROCODONE BITARTRATE AND ACETAMINOPHEN30 in 1 BLISTER PACKTABLET307
12634-264-61HYDROCODONE BITARTRATE AND ACETAMINOPHEN10 in 1 BLISTER PACKTABLET107
12634-264-64HYDROCODONE BITARTRATE AND ACETAMINOPHEN4 in 1 BLISTER PACKTABLET47
12634-264-65HYDROCODONE BITARTRATE AND ACETAMINOPHEN5 in 1 BLISTER PACKTABLET57
12634-264-66HYDROCODONE BITARTRATE AND ACETAMINOPHEN6 in 1 BLISTER PACKTABLET67
12634-264-71HYDROCODONE BITARTRATE AND ACETAMINOPHEN30 in 1 BOTTLETABLET307
12634-264-80HYDROCODONE BITARTRATE AND ACETAMINOPHEN20 in 1 BOTTLETABLET207
12634-264-82HYDROCODONE BITARTRATE AND ACETAMINOPHEN12 in 1 BOTTLE, PLASTICTABLET127
12634-264-85HYDROCODONE BITARTRATE AND ACETAMINOPHEN15 in 1 BOTTLETABLET157
12634-264-91HYDROCODONE BITARTRATE AND ACETAMINOPHEN1 in 1 BLISTER PACKTABLET17
12634-264-92HYDROCODONE BITARTRATE AND ACETAMINOPHEN2 in 1 BOTTLE, PLASTICTABLET27
12634-264-94HYDROCODONE BITARTRATE AND ACETAMINOPHEN4 in 1 BOTTLE, PLASTICTABLET47
12634-264-95HYDROCODONE BITARTRATE AND ACETAMINOPHEN5 in 1 BOTTLE, PLASTICTABLET57
12634-264-96HYDROCODONE BITARTRATE AND ACETAMINOPHEN6 in 1 BOTTLE, PLASTICTABLET67

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-264HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA INC.]7Legacy NDC, 18 package rows20160618_2ec4d6a5-d2a3-4c91-9d61-afeb3abd17af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN2ec4d6a5-d2a3-4c91-9d61-afeb3abd17af7
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD2ec4d6a5-d2a3-4c91-9d61-afeb3abd17af7
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY2ec4d6a5-d2a3-4c91-9d61-afeb3abd17af7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-264-001263402640010 in 1 BOTTLEHistorical
12634-264-401263402644040 in 1 BOTTLE, PLASTICHistorical
12634-264-501263402645050 in 1 BOTTLE, PLASTICHistorical
12634-264-571263402645720 in 1 BLISTER PACKHistorical
12634-264-591263402645930 in 1 BLISTER PACKHistorical
12634-264-611263402646110 in 1 BLISTER PACKHistorical
12634-264-64126340264644 in 1 BLISTER PACKHistorical
12634-264-65126340264655 in 1 BLISTER PACKHistorical
12634-264-66126340264666 in 1 BLISTER PACKHistorical
12634-264-711263402647130 in 1 BOTTLEHistorical
12634-264-801263402648020 in 1 BOTTLEHistorical
12634-264-821263402648212 in 1 BOTTLE, PLASTICHistorical
12634-264-851263402648515 in 1 BOTTLEHistorical
12634-264-91126340264911 in 1 BLISTER PACKHistorical
12634-264-92126340264922 in 1 BOTTLE, PLASTICHistorical
12634-264-94126340264944 in 1 BOTTLE, PLASTICHistorical
12634-264-95126340264955 in 1 BOTTLE, PLASTICHistorical
12634-264-96126340264966 in 1 BOTTLE, PLASTICHistorical