FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Manufacturer
Northwind Pharmaceuticals | EPM Packaging
Effective date
2015-07-31
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:22:08

Label at a glance#

ProductHydrocodone Bitartrate and Acetaminophen
Active ingredientHYDROCODONE BITARTRATE, ACETAMINOPHEN
Label structure1 sections

Label contents#

Full prescribing information#

Package Label.Principal Display Panel

NDC: 51655-804-27

HYDROCODONE BIT & ACETAMINOPHEN 7.5MG/325MG CII

12 Tablets

Rx Only

Lot:

Exp:

Store at 20C to 25C (68-77F)

Keep out of reach of children.

Dosage: See package insert.

Manufactured By: Aurolife Pharma LLC

Manufacture Address: Dayton, NJ 08810

Manufacture NDC: 13107-020-05

Mfg Lot: 020150016B

Distributed by: Northwind Pharmaceuticals Indianapolis, IN 46256

Rx#:

51655-804-2751655-804-27

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-804-272026-01-10C16284748780-19d75b9d0-fb4a-f424-e053-dadaa90a57ce2dddb4be-83ed-0cbe-e054-00144ff88e88
51655-804-272020-01-31C16284748780-19d75b9d0-fb4a-f424-e053-dadaa90a57ce2dddb4be-83ed-0cbe-e054-00144ff88e88

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-804HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [NORTHWIND PHARMACEUTICALS]1Legacy NDC20160314_2dddb4be-83ed-0cbe-e054-00144ff88e88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-020-01EA - Each13107-0204e036482-3169-422f-abe9-f21388701b9112013-02-13
13107-020-05EA - Each13107-020090cd39b-1b7f-4875-8f96-0be084ba386612013-02-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51655-80451655-804-27
13107-020

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
POVIDONE K30U725QWY32XIACT
STARCH, CORNO8232NY3SJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HYDROCODONE BITARTRATENO70W886KKACTIB
ACETAMINOPHEN362O9ITL9DACTIB
CROSPOVIDONE68401960MKIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORALAA2012-04-11
A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;7.5MGTABLET / ORALAA2012-04-11
A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;10MGTABLET / ORALAA2012-04-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A201013-001AA
A201013-002AA
A201013-003AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-1184e616aacf4f…
2026-09-14 22:38:342026-08A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-1184e616aacf4f…
2026-09-14 22:38:342026-08A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-1184e616aacf4f…
2026-08-18 06:07:402026-07A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11caaa826d4ba7…
2026-08-18 06:07:402026-07A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11caaa826d4ba7…
2026-08-18 06:07:402026-07A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2012-04-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2012-04-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201013-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2012-04-11301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A201013-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A201013-002AA184e616aacf4f…
2026-09-14 22:38:342026-08A201013-003AA184e616aacf4f…
2026-08-18 06:07:402026-07A201013-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A201013-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A201013-003AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201013-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201013-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201013-003AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201013-003AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201013-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201013-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201013-003AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201013-003AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201013-003AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201013-003AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201013-003AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201013-003AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201013-003AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201013-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201013-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201013-003AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201013-003AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201013-001AA1301d65b070ca…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
479caeb3-31d0-56c4-e063-6294a90aa7102dddb4be-83ed-0cbe-e054-00144ff88e882026-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: 2dddb4be-83ed-0cbe-e054-00144ff88e88
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAurolife Pharma, LLC60f43308-1deb-4f05-8f17-aa49ebdcf4982025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 13107-020

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.