FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
71335-9734
11-digit product format
713359734
Labeler code
71335
Product ID
71335-9734_368725ec-f1df-4f17-a2e0-3bd5d4cb89d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202214
Marketing category
ANDA
Marketing start
2014-10-06
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocodone Bitartrate and Acetaminophen
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-9734-0Hydrocodone Bitartrate and Acetaminophen10 in 1 BOTTLE, PLASTICTABLET10107
71335-9734-1Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLE, PLASTICTABLET30107
71335-9734-2Hydrocodone Bitartrate and Acetaminophen120 in 1 BOTTLE, PLASTICTABLET120107
71335-9734-3Hydrocodone Bitartrate and Acetaminophen20 in 1 BOTTLE, PLASTICTABLET20107
71335-9734-4Hydrocodone Bitartrate and Acetaminophen60 in 1 BOTTLE, PLASTICTABLET60107
71335-9734-5Hydrocodone Bitartrate and Acetaminophen90 in 1 BOTTLE, PLASTICTABLET90107
71335-9734-6Hydrocodone Bitartrate and Acetaminophen50 in 1 BOTTLE, PLASTICTABLET50107
71335-9734-7Hydrocodone Bitartrate and Acetaminophen40 in 1 BOTTLE, PLASTICTABLET40107
71335-9734-8Hydrocodone Bitartrate and Acetaminophen15 in 1 BOTTLE, PLASTICTABLET15107
71335-9734-9Hydrocodone Bitartrate and Acetaminophen84 in 1 BOTTLE, PLASTICTABLET84107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9734-0EA - Each71335-9734a4e95e78-09a3-484a-91a7-39ff5bb2ce9812023-10-16
71335-9734-1EA - Each71335-9734562ee014-21f4-47da-98e2-aebaf4245b1812023-10-16
71335-9734-2EA - Each71335-97348b41246c-a93d-43ca-bd7f-3515200992ba12023-10-16
71335-9734-3EA - Each71335-97345a4f1d20-d8ce-4f63-ad90-7107866f888b12023-10-16
71335-9734-4EA - Each71335-9734637cf5ae-e7bd-4ca2-9f62-29ee91a5c9cc12023-10-16
71335-9734-5EA - Each71335-973468bf4702-1705-42f8-9a66-8829b01d99c512023-10-16
71335-9734-7EA - Each71335-9734a5894328-8abf-42f2-868f-c647d0589b4612023-10-16
71335-9734-8EA - Each71335-9734a8ffca25-105a-4615-b434-76533eb0f89812023-10-16
71335-9734-9EA - Each71335-97340a6739fd-3117-49a5-8420-965318df63e912023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9734HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]106Current NDC, 10 package rows20240828_8e99994a-83b4-4b1f-9654-4ae373bf2c4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN8e99994a-83b4-4b1f-9654-4ae373bf2c4d107
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD8e99994a-83b4-4b1f-9654-4ae373bf2c4d107
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY8e99994a-83b4-4b1f-9654-4ae373bf2c4d107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9734-07133597340010 TABLET in 1 BOTTLE, PLASTIC (71335-9734-0) 10 tablet2023-06-08NoNoHistorical
71335-9734-17133597340130 TABLET in 1 BOTTLE, PLASTIC (71335-9734-1) 30 tablet2023-05-15NoNoHistorical
71335-9734-271335973402120 TABLET in 1 BOTTLE, PLASTIC (71335-9734-2) 120 tablet2023-05-30NoNoHistorical
71335-9734-37133597340320 TABLET in 1 BOTTLE, PLASTIC (71335-9734-3) 20 tablet2023-05-30NoNoHistorical
71335-9734-47133597340460 TABLET in 1 BOTTLE, PLASTIC (71335-9734-4) 60 tablet2023-06-02NoNoHistorical
71335-9734-57133597340590 TABLET in 1 BOTTLE, PLASTIC (71335-9734-5) 90 tablet2023-10-18NoNoHistorical
71335-9734-67133597340650 TABLET in 1 BOTTLE, PLASTIC (71335-9734-6) 50 tablet2026-04-09NoNoHistorical
71335-9734-77133597340740 TABLET in 1 BOTTLE, PLASTIC (71335-9734-7) 40 tablet2023-10-17NoNoHistorical
71335-9734-87133597340815 TABLET in 1 BOTTLE, PLASTIC (71335-9734-8) 15 tablet2023-05-30NoNoHistorical
71335-9734-97133597340984 TABLET in 1 BOTTLE, PLASTIC (71335-9734-9) 84 tablet2026-04-09NoNoHistorical