FDA.reportPublic FDA data

hydrocodone bitartrate and acetaminophen

Product NDC
27808-130
11-digit product format
278080130
Labeler code
27808
Product ID
27808-130_5b4bd464-17c3-42af-a519-ef795299e692
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocodone bitartrate and acetaminophen
Dosage form
SOLUTION
Route
ORAL
Labeler
Cranbury Pharmaceuticals, LLC
Application
ANDA201295
Marketing category
ANDA
Marketing start
2021-12-30
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
300; 10 mg/15mL; mg/15mL
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
ACETAMINOPHEN300 mg/15mL
HYDROCODONE BITARTRATE10 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, NO70W886KK
Rxcui1044427

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
27808-130-01hydrocodone bitartrate and acetaminophen473 mL in 1 BOTTLE, PLASTICSOLUTION47323

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27808-130HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [TRIS PHARMA INC]17Current NDC, Legacy NDC, 1 package rows20240305_93b6dfdf-ba6e-4ea6-ab85-5ac121e33101.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044427HYDROcodone bitartrate 10 MG / acetaminophen 300 MG in 15 mL Oral SolutionPSN93b6dfdf-ba6e-4ea6-ab85-5ac121e3310123
1044427acetaminophen 20 MG/ML / hydrocodone bitartrate 0.667 MG/ML Oral SolutionSCD93b6dfdf-ba6e-4ea6-ab85-5ac121e3310123
1044427APAP 20 MG/ML / Hydrocodone Bitartrate 0.667 MG/ML Oral SolutionSY93b6dfdf-ba6e-4ea6-ab85-5ac121e3310123
1044427APAP 300 MG / hydrocodone bitartrate 10 MG per 15 ML Oral SolutionSY93b6dfdf-ba6e-4ea6-ab85-5ac121e3310123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27808-130-0127808013001473 mL in 1 BOTTLE, PLASTIC (27808-130-01) 473 ml2022-12-300000-00-00NoNoCurrent