FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
71335-1418
11-digit product format
713351418
Labeler code
71335
Product ID
71335-1418_7b2d0858-c622-4f2b-a484-d3104af006e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202991
Marketing category
ANDA
Marketing start
2016-04-12
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 10 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
HYDROCODONE BITARTRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, NO70W886KK
Rxcui856999

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
71335-1418-0Hydrocodone Bitartrate and Acetaminophen120 in 1 BOTTLETABLET120103
71335-1418-1Hydrocodone Bitartrate and Acetaminophen20 in 1 BOTTLETABLET20103
71335-1418-2Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET30103
71335-1418-3Hydrocodone Bitartrate and Acetaminophen40 in 1 BOTTLETABLET40103
71335-1418-4Hydrocodone Bitartrate and Acetaminophen45 in 1 BOTTLETABLET45103
71335-1418-5Hydrocodone Bitartrate and Acetaminophen56 in 1 BOTTLETABLET56103
71335-1418-6Hydrocodone Bitartrate and Acetaminophen60 in 1 BOTTLETABLET60103
71335-1418-7Hydrocodone Bitartrate and Acetaminophen84 in 1 BOTTLETABLET84103
71335-1418-8Hydrocodone Bitartrate and Acetaminophen90 in 1 BOTTLETABLET90103
71335-1418-9Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLETABLET100103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1418-0EA - Each71335-1418162038ff-004b-4f11-8ae2-2d50ab2af46612021-08-05
71335-1418-1EA - Each71335-14182d88d2cc-6731-47a3-9e11-2d97d920f3d112021-08-05
71335-1418-2EA - Each71335-1418f25fb6c6-5af5-4e85-acfd-3906d62c551812021-01-08
71335-1418-6EA - Each71335-1418d2e133b2-757f-4d78-b2a4-b70dd614cdfa12021-01-08
71335-1418-8EA - Each71335-141841bc12ed-44d1-4f97-8495-bfc9a0163bd712021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1418HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20240725_e83d90f9-513b-47c2-ae2a-748ce775ef5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNe83d90f9-513b-47c2-ae2a-748ce775ef5d103
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDe83d90f9-513b-47c2-ae2a-748ce775ef5d103
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYe83d90f9-513b-47c2-ae2a-748ce775ef5d103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1418-071335141800120 TABLET in 1 BOTTLE (71335-1418-0) 120 tablet2019-12-060000-00-00NoNoCurrent
71335-1418-17133514180120 TABLET in 1 BOTTLE (71335-1418-1) 20 tablet2020-02-130000-00-00NoNoCurrent
71335-1418-27133514180230 TABLET in 1 BOTTLE (71335-1418-2) 30 tablet2019-12-060000-00-00NoNoCurrent
71335-1418-37133514180340 TABLET in 1 BOTTLE (71335-1418-3) 40 tablet2024-07-090000-00-00NoNoCurrent
71335-1418-47133514180445 TABLET in 1 BOTTLE (71335-1418-4) 45 tablet2024-07-090000-00-00NoNoCurrent
71335-1418-57133514180556 TABLET in 1 BOTTLE (71335-1418-5) 56 tablet2024-07-090000-00-00NoNoCurrent
71335-1418-67133514180660 TABLET in 1 BOTTLE (71335-1418-6) 60 tablet2019-12-090000-00-00NoNoCurrent
71335-1418-77133514180784 TABLET in 1 BOTTLE (71335-1418-7) 84 tablet2024-07-090000-00-00NoNoCurrent
71335-1418-87133514180890 TABLET in 1 BOTTLE (71335-1418-8) 90 tablet2020-01-060000-00-00NoNoCurrent
71335-1418-971335141809100 TABLET in 1 BOTTLE (71335-1418-9) 100 tablet2024-07-090000-00-00NoNoCurrent