FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
43386-351
11-digit product format
433860351
Labeler code
43386
Product ID
43386-351_cc982f78-de8c-4384-9f43-ffad4169abdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals,Inc.
Application
ANDA206142
Marketing category
ANDA
Marketing start
2016-11-14
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
300; 5 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A206142-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE300MG;5MGTABLET / ORAL2016-11-14
A206142-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE300MG;7.5MGTABLET / ORAL2016-11-14
A206142-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE300MG;10MGTABLET / ORAL2016-11-14

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206142-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORAL2016-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206142-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORAL2016-11-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206142-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORAL2016-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206142-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORAL2016-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206142-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORAL2016-11-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206142-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORAL2016-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A206142-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORAL2016-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206142-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORAL2016-11-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206142-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORAL2016-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206142-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORAL2016-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206142-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORAL2016-11-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206142-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORAL2016-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206142-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORAL2016-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206142-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORAL2016-11-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206142-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORAL2016-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206142-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORAL2016-11-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206142-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORAL2016-11-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206142-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORAL2016-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206142-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORAL2016-11-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206142-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORAL2016-11-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206142-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORAL2016-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206142-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORAL2016-11-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206142-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORAL2016-11-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206142-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORAL2016-11-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206142-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORAL2016-11-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206142-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORAL2016-11-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206142-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORAL2016-11-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206142-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORAL2016-11-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A206142-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORAL2016-11-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A206142-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORAL2016-11-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206142-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORAL2016-11-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206142-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORAL2016-11-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206142-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORAL2016-11-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206142-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORAL2016-11-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206142-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORAL2016-11-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206142-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORAL2016-11-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206142-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORAL2016-11-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206142-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORAL2016-11-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206142-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORAL2016-11-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206142-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORAL2016-11-148072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206142-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206142-002AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206142-003AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206142-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206142-002AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206142-003AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206142-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206142-002AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206142-003AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206142-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206142-002AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206142-003AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206142-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206142-002AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206142-003AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206142-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A206142-002AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A206142-003AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206142-001AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206142-002AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206142-003AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A206142-001AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A206142-002AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A206142-003AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206142-001AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A206142-002AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A206142-003AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206142-001AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A206142-002AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A206142-003AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206142-001AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A206142-002AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A206142-003AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A206142-001AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A206142-002AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A206142-003AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206142-001AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A206142-002AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A206142-003AA1ea99ee380514…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206142-001AA1a72a2bbeb626…

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocodone Bitartrate and Acetaminophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCODONE BITARTRATE300 mg/1
ACETAMINOPHEN5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
NO70W886KKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856980Internal RxNorm lookup
856987Internal RxNorm lookup
856992Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
48cc1378-ffab-4645-95bb-a05d78066575Available on FDA.report

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
43386-351-01Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLETABLET1008
43386-351-03Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLETABLET308
43386-351-05Hydrocodone Bitartrate and Acetaminophen500 in 1 BOTTLETABLET5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-351-01EA - Each43386-351d920dd87-7e0c-4532-9aa2-e1876f85bd1e12017-05-03
43386-351-05EA - Each43386-3513b937ca3-5531-4cfb-b5d1-fc4aa5ee72b712017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-351HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [LUPIN PHARMACEUTICALS,INC.]8Current NDC, Legacy NDC, 3 package rows20241204_48cc1378-ffab-4645-95bb-a05d78066575.zip

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENLupin Pharmaceuticals,Inc.48cc1378-ffab-4645-95bb-a05d780665752024-02-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206142
application number: ANDA206142
ndc (product): 43386-351

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856980HYDROcodone bitartrate 10 MG / acetaminophen 300 MG Oral TabletPSN48cc1378-ffab-4645-95bb-a05d780665758
856987HYDROcodone bitartrate 5 MG / acetaminophen 300 MG Oral TabletPSN48cc1378-ffab-4645-95bb-a05d780665758
856992HYDROcodone bitartrate 7.5 MG / acetaminophen 300 MG Oral TabletPSN48cc1378-ffab-4645-95bb-a05d780665758
856980acetaminophen 300 MG / hydrocodone bitartrate 10 MG Oral TabletSCD48cc1378-ffab-4645-95bb-a05d780665758
856987acetaminophen 300 MG / hydrocodone bitartrate 5 MG Oral TabletSCD48cc1378-ffab-4645-95bb-a05d780665758
856992acetaminophen 300 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD48cc1378-ffab-4645-95bb-a05d780665758
856980APAP 300 MG / hydrocodone bitartrate 10 MG Oral TabletSY48cc1378-ffab-4645-95bb-a05d780665758
856987APAP 300 MG / hydrocodone bitartrate 5 MG Oral TabletSY48cc1378-ffab-4645-95bb-a05d780665758
856992APAP 300 MG / Hydrocodone Bitartrate 7.5 MG Oral TabletSY48cc1378-ffab-4645-95bb-a05d780665758

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43386-351-0143386035101100 TABLET in 1 BOTTLE (43386-351-01) 100 tablet2016-11-140000-00-00NoNoCurrent
43386-351-034338603510330 TABLET in 1 BOTTLE (43386-351-03) 30 tablet2016-11-140000-00-00NoNoCurrent
43386-351-0543386035105500 TABLET in 1 BOTTLE (43386-351-05) 500 tablet2016-11-140000-00-00NoNoCurrent