FDA.reportPublic FDA data

HYDROCODONE BITARTRATE

Product NDC
61919-494
11-digit product format
619190494
Labeler code
61919
Product ID
61919-494_f2147260-be71-3f01-e053-2995a90ac7b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTRATE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA040736
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2024-12-31
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
61919-494-302025-01-30C16284748780-19d75b9d0-d690-f424-e053-dadaa90a57ceHYDROCODONE BITARTRATE
61919-494-602025-01-30C16284748780-19d75b9d0-d690-f424-e053-dadaa90a57ceHYDROCODONE BITARTRATE
61919-494-722025-01-30C16284748780-19d75b9d0-d690-f424-e053-dadaa90a57ceHYDROCODONE BITARTRATE
61919-494-902025-01-30C16284748780-19d75b9d0-d690-f424-e053-dadaa90a57ceHYDROCODONE BITARTRATE
61919-494-082023-01-30C16284748780-1f386c64a-2260-0266-e053-dadaa90a7c1aHYDROCODONE BITARTRATE
61919-494-202023-01-30C16284748780-1f386c64a-2260-0266-e053-dadaa90a7c1aHYDROCODONE BITARTRATE
61919-494-722022-09-30C16284748780-19d75b9d0-d690-f424-e053-dadaa90a57ceHYDROCODONE BITARTRATE
61919-494-722020-01-31C16284748780-19d75b9d0-d690-f424-e053-dadaa90a57ceHYDROCODONE BITARTRATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-494-30HYDROCODONE BITARTRATE30 in 1 BOTTLETABLET3010
61919-494-60HYDROCODONE BITARTRATE60 in 1 BOTTLETABLET6010
61919-494-72HYDROCODONE BITARTRATE120 in 1 BOTTLETABLET12010
61919-494-90HYDROCODONE BITARTRATE90 in 1 BOTTLETABLET9010
61919-494-08HYDROCODONE BITARTRATE8 in 1 BOTTLETABLET84
61919-494-20HYDROCODONE BITARTRATE20 in 1 BOTTLETABLET204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-494-08EA - Each61919-494a2f7a0ed-3147-432b-9d60-ad137a72181d12021-07-15
61919-494-20EA - Each61919-494b9c1d797-cd12-4c1e-b865-40aa61b0a5f512019-08-06
61919-494-30EA - Each61919-4949782b6df-dc1d-4352-b23c-55b91276614212014-06-03
61919-494-60EA - Each61919-4943f940aa4-e9d9-493b-a968-9456deda3e4912014-06-03
61919-494-72EA - Each61919-494f96002eb-f831-4966-b93f-a4f51ed2e1ff12015-10-02
61919-494-90EA - Each61919-4948c383bd8-3a00-4acb-b6c1-df577c7b931812014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE TABLET [DIRECT RX]2
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE TABLET [DIRECT RX]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE TABLET [DIRECT RX]2
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE TABLET [DIRECT RX]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE TABLET [DIRECT RX]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE TABLET [DIRECT RX]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE TABLET [DIRECT RX]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE TABLET [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-494HYDROCODONE BITARTRATE TABLET [DIRECT RX]10Legacy NDC, 4 package rows20230428_fa2a09a8-7835-4261-a9b1-b35adab27de7.zip
61919-494HYDROCODONE BITARTRATE TABLET [DIRECT_RX]4Legacy NDC, 2 package rows20210608_8e5b9848-283b-5fbf-e053-2a95a90ad5a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNfa2a09a8-7835-4261-a9b1-b35adab27de710
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDfa2a09a8-7835-4261-a9b1-b35adab27de710
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYfa2a09a8-7835-4261-a9b1-b35adab27de710
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN8e5b9848-283b-5fbf-e053-2a95a90ad5a14
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD8e5b9848-283b-5fbf-e053-2a95a90ad5a14
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY8e5b9848-283b-5fbf-e053-2a95a90ad5a14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-494-08619190494088 TABLET in 1 BOTTLE (61919-494-08) 8 tablet2019-07-230000-00-00NoNoCurrent
61919-494-206191904942020 TABLET in 1 BOTTLE (61919-494-20) 20 tablet2019-07-230000-00-00NoNoCurrent
61919-494-306191904943030 TABLET in 1 BOTTLE (61919-494-30) 30 tablet2014-01-010000-00-00NoNoCurrent
61919-494-606191904946060 TABLET in 1 BOTTLE (61919-494-60) 60 tablet2014-01-010000-00-00NoNoCurrent
61919-494-7261919049472120 TABLET in 1 BOTTLE (61919-494-72) 120 tablet2014-01-010000-00-00NoNoCurrent
61919-494-906191904949090 TABLET in 1 BOTTLE (61919-494-90) 90 tablet2014-01-010000-00-00NoNoCurrent