FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
27808-037
11-digit product format
278080037
Labeler code
27808
Product ID
27808-037_cf89ef14-b1bb-4341-8911-892ce7d157c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Cranbury Pharmaceuticals, LLC
Application
ANDA202214
Marketing category
ANDA
Marketing start
2014-10-06
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
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNO70W886KK, 362O9ITL9D
Rxcui856999, 857002, 857005

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
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
377068df-225f-7318-a910-a1987cdfa361Product name320170608
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
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27808-037-01Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLE, PLASTICTABLET10036
27808-037-02Hydrocodone Bitartrate and Acetaminophen500 in 1 BOTTLE, PLASTICTABLET50036
27808-037-03Hydrocodone Bitartrate and Acetaminophen1000 in 1 BOTTLE, PLASTICTABLET100036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27808-037-01EA - Each27808-037b073c623-8560-4010-a59b-e0bb35a2bafc12014-07-02
27808-037-02EA - Each27808-0371ca899ee-220d-4181-868f-3498db8d016212014-07-02
27808-037-03EA - Each27808-037a06a68f3-2586-45fb-85f0-81ddacf8117512015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [TRIS PHARMA INC]5
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [TRIS PHARMA INC]5
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [TRIS PHARMA INC]5
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [TRIS PHARMA INC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [TRIS PHARMA INC]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [TRIS PHARMA INC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [TRIS PHARMA INC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [TRIS PHARMA INC]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [TRIS PHARMA INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27808-037HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [CRANBURY PHARMACEUTICALS, LLC]32Current NDC, Legacy NDC, 3 package rows20250130_d4caec6d-4af2-4f1c-9add-c0c948b83b16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNb1e520d2-0347-4399-a765-fcacbc50f288107
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN6dde2f85-e329-4bca-832d-d45786df9f52107
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDb1e520d2-0347-4399-a765-fcacbc50f288107
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD6dde2f85-e329-4bca-832d-d45786df9f52107
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY6dde2f85-e329-4bca-832d-d45786df9f52107
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYb1e520d2-0347-4399-a765-fcacbc50f288107
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN9698729e-08d0-483c-b157-5a4061d97065106
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD9698729e-08d0-483c-b157-5a4061d97065106
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY9698729e-08d0-483c-b157-5a4061d97065106
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN679b4f87-59df-48d4-a9e6-e78aaeab23ea105
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD679b4f87-59df-48d4-a9e6-e78aaeab23ea105
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY679b4f87-59df-48d4-a9e6-e78aaeab23ea105
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNf7b554ab-2996-4cf0-a498-01cd5ef5df4f104
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDf7b554ab-2996-4cf0-a498-01cd5ef5df4f104
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYf7b554ab-2996-4cf0-a498-01cd5ef5df4f104
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNfa88d7b2-6c8e-4893-bd81-ecd4f2aca493100
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDfa88d7b2-6c8e-4893-bd81-ecd4f2aca493100
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYfa88d7b2-6c8e-4893-bd81-ecd4f2aca493100
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNd4caec6d-4af2-4f1c-9add-c0c948b83b1636
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNd4caec6d-4af2-4f1c-9add-c0c948b83b1636
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSNd4caec6d-4af2-4f1c-9add-c0c948b83b1636
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDd4caec6d-4af2-4f1c-9add-c0c948b83b1636
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDd4caec6d-4af2-4f1c-9add-c0c948b83b1636
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDd4caec6d-4af2-4f1c-9add-c0c948b83b1636
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYd4caec6d-4af2-4f1c-9add-c0c948b83b1636
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYd4caec6d-4af2-4f1c-9add-c0c948b83b1636
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSYd4caec6d-4af2-4f1c-9add-c0c948b83b1636
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN681a949d-7c90-9dfd-e053-2a91aa0aad075
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD681a949d-7c90-9dfd-e053-2a91aa0aad075
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY681a949d-7c90-9dfd-e053-2a91aa0aad075
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSNba7d27eb-952d-4e99-95b9-5b0b2f85794b3
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSNba7d27eb-952d-4e99-95b9-5b0b2f85794b3
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSNba7d27eb-952d-4e99-95b9-5b0b2f85794b3
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCDba7d27eb-952d-4e99-95b9-5b0b2f85794b3
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCDba7d27eb-952d-4e99-95b9-5b0b2f85794b3
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDba7d27eb-952d-4e99-95b9-5b0b2f85794b3
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSYba7d27eb-952d-4e99-95b9-5b0b2f85794b3
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSYba7d27eb-952d-4e99-95b9-5b0b2f85794b3
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSYba7d27eb-952d-4e99-95b9-5b0b2f85794b3
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN4135fb50-2e77-7365-e063-6294a90a8c432
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD4135fb50-2e77-7365-e063-6294a90a8c432
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY4135fb50-2e77-7365-e063-6294a90a8c432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27808-037-0127808003701100 TABLET in 1 BOTTLE, PLASTIC (27808-037-01) 100 tablet2014-10-060000-00-00NoNoCurrent
27808-037-0227808003702500 TABLET in 1 BOTTLE, PLASTIC (27808-037-02) 500 tablet2014-10-060000-00-00NoNoCurrent
27808-037-03278080037031000 TABLET in 1 BOTTLE, PLASTIC (27808-037-03) 1000 tablet2014-10-060000-00-00NoNoCurrent