FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
63629-5422
11-digit product format
636295422
Labeler code
63629
Product ID
63629-5422_1960bda9-b48f-4f7a-949a-b9fb8ab1ed67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040736
Marketing category
ANDA
Marketing start
2010-01-18
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 5 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocodone Bitartrate and Acetaminophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
HYDROCODONE BITARTRATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, NO70W886KK
Rxcui857002

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
63629-5422-12020-10-28C16284748780-19d75b9d0-de52-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-22020-10-28C16284748780-19d75b9d0-de52-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-32020-10-28C16284748780-19d75b9d0-de52-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-42020-10-28C16284748780-19d75b9d0-de52-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-52020-10-28C16284748780-19d75b9d0-de52-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-62020-10-28C16284748780-19d75b9d0-de52-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-72020-10-28C16284748780-19d75b9d0-de52-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-82020-10-28C16284748780-19d75b9d0-de52-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-92020-10-28C16284748780-19d75b9d0-de52-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-12020-01-31C16284748780-19d75b9d0-de52-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-22020-01-31C16284748780-19d75b9d0-de52-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-32020-01-31C16284748780-19d75b9d0-de52-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-42020-01-31C16284748780-19d75b9d0-de52-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-52020-01-31C16284748780-19d75b9d0-de52-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-62020-01-31C16284748780-19d75b9d0-de52-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-72020-01-31C16284748780-19d75b9d0-de52-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-82020-01-31C16284748780-19d75b9d0-de52-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)
63629-5422-92020-01-31C16284748780-19d75b9d0-de52-f424-e053-dadaa90a57ceHydrocodone Bitartrate and Acetaminophen Tablets, USP CII (5 mg/325 mg)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-5422-0Hydrocodone Bitartrate and Acetaminophen10 in 1 BOTTLETABLET101008
63629-5422-1Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET301008
63629-5422-2Hydrocodone Bitartrate and Acetaminophen120 in 1 BOTTLETABLET1201008
63629-5422-3Hydrocodone Bitartrate and Acetaminophen20 in 1 BOTTLETABLET201008
63629-5422-4Hydrocodone Bitartrate and Acetaminophen60 in 1 BOTTLETABLET601008
63629-5422-5Hydrocodone Bitartrate and Acetaminophen90 in 1 BOTTLETABLET901008
63629-5422-6Hydrocodone Bitartrate and Acetaminophen50 in 1 BOTTLETABLET501008
63629-5422-7Hydrocodone Bitartrate and Acetaminophen40 in 1 BOTTLETABLET401008
63629-5422-8Hydrocodone Bitartrate and Acetaminophen15 in 1 BOTTLETABLET151008
63629-5422-9Hydrocodone Bitartrate and Acetaminophen84 in 1 BOTTLETABLET841008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-5422-0EA - Each63629-5422c89d9082-333a-40d3-af9e-3df165d4824f12025-10-14
63629-5422-1EA - Each63629-542297268d02-08fd-4c46-a8f6-535a6586c93512015-10-02
63629-5422-2EA - Each63629-542212c1ff80-9ce2-4556-8861-3ea591d8c1bf12015-10-02
63629-5422-3EA - Each63629-5422d1e5ee23-7416-4227-b349-025b58abbce112016-05-16
63629-5422-4EA - Each63629-5422a9873c7d-fb95-49cc-aae4-b82fd0bd572512016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1003
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1003
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1003
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1003
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1003
POVIDONESINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1003
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1003
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]1003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNa200d099-fa55-4ef1-b8d7-936a7da1db001008
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDa200d099-fa55-4ef1-b8d7-936a7da1db001008
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYa200d099-fa55-4ef1-b8d7-936a7da1db001008

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-5422-06362954220010 TABLET in 1 BOTTLE (63629-5422-0) 10 tablet2017-07-250000-00-00NoNoCurrent
63629-5422-16362954220130 TABLET in 1 BOTTLE (63629-5422-1) 30 tablet2014-10-060000-00-00NoNoCurrent
63629-5422-263629542202120 TABLET in 1 BOTTLE (63629-5422-2) 120 tablet2014-10-140000-00-00NoNoCurrent
63629-5422-36362954220320 TABLET in 1 BOTTLE (63629-5422-3) 20 tablet2014-10-060000-00-00NoNoCurrent
63629-5422-46362954220460 TABLET in 1 BOTTLE (63629-5422-4) 60 tablet2014-10-060000-00-00NoNoCurrent
63629-5422-56362954220590 TABLET in 1 BOTTLE (63629-5422-5) 90 tablet2014-10-060000-00-00NoNoCurrent
63629-5422-66362954220650 TABLET in 1 BOTTLE (63629-5422-6) 50 tablet2019-12-220000-00-00NoNoCurrent
63629-5422-76362954220740 TABLET in 1 BOTTLE (63629-5422-7) 40 tablet2014-10-230000-00-00NoNoCurrent
63629-5422-86362954220815 TABLET in 1 BOTTLE (63629-5422-8) 15 tablet2014-11-030000-00-00NoNoCurrent
63629-5422-96362954220984 TABLET in 1 BOTTLE (63629-5422-9) 84 tablet2014-12-010000-00-00NoNoCurrent