FDA.reportPublic FDA data

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC
12634-264
11-digit product format
126340264
Labeler code
12634
Product ID
12634-264_357d7f87-1694-2dc5-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocodone bitartrate and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA040099
Marketing category
ANDA
Marketing start
1997-06-25
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
5 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 19 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct12634-264IInactivated by FDA2026-10-05
excluded packagepackage12634-26412634-264-00IInactivated by FDA2026-10-05
excluded packagepackage12634-26412634-264-40IInactivated by FDA2026-10-05
excluded packagepackage12634-26412634-264-50IInactivated by FDA2026-10-05
excluded packagepackage12634-26412634-264-57IInactivated by FDA2026-10-05
excluded packagepackage12634-26412634-264-59IInactivated by FDA2026-10-05
excluded packagepackage12634-26412634-264-61IInactivated by FDA2026-10-05
excluded packagepackage12634-26412634-264-64IInactivated by FDA2026-10-05
excluded packagepackage12634-26412634-264-65IInactivated by FDA2026-10-05
excluded packagepackage12634-26412634-264-66IInactivated by FDA2026-10-05
excluded packagepackage12634-26412634-264-71IInactivated by FDA2026-10-05
excluded packagepackage12634-26412634-264-80IInactivated by FDA2026-10-05
excluded packagepackage12634-26412634-264-82IInactivated by FDA2026-10-05
excluded packagepackage12634-26412634-264-85IInactivated by FDA2026-10-05
excluded packagepackage12634-26412634-264-91IInactivated by FDA2026-10-05
excluded packagepackage12634-26412634-264-92IInactivated by FDA2026-10-05
excluded packagepackage12634-26412634-264-94IInactivated by FDA2026-10-05
excluded packagepackage12634-26412634-264-95IInactivated by FDA2026-10-05
excluded packagepackage12634-26412634-264-96IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 7 · 399 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-264-71d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-264-66d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-264-91d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-264-64d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-264-65d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-264-57d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-264-85d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-264-96d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-264-80d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-264-94d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-264-82d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-264-00d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-264-61d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-264-92d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-264-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-264-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-264-95d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-264-59d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-264-71f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-264-66f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-264-91f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-264-64f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-264-65f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-264-57f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-264-85f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-264-96f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-264-80f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-264-94f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-264-82f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-264-00f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-264-61f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-264-92f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-264-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-264-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-264-95f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-264-59f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage12634-264-712ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage12634-264-662ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage12634-264-912ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage12634-264-642ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage12634-264-652ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage12634-264-572ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage12634-264-852ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage12634-264-962ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage12634-264-802ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage12634-264-942ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage12634-264-822ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage12634-264-002ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage12634-264-612ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage12634-264-922ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage12634-264-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage12634-264-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage12634-264-952ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage12634-264-592ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage12634-264-71a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage12634-264-66a1b67e2a42f9…c4cf2c586c0d…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040099-001NORCOACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORAL1997-06-25

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-2584e616aacf4f…
2026-08-18 06:07:402026-07A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040099-001NORCO325MG;5MGTABLET / ORALAARS1997-06-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040099-001NORCO325MG;5MGTABLET / ORALAARS1997-06-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A040099-001NORCO325MG;5MGTABLET / ORALAARS1997-06-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040099-001NORCO325MG;5MGTABLET / ORALAARS1997-06-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040099-001NORCO325MG;5MGTABLET / ORALAARS1997-06-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040099-001NORCO325MG;5MGTABLET / ORALAARS1997-06-253f01610625f2…
2019-09-15 20:21 UTC2019-09A040099-001NORCO325MG;5MGTABLET / ORALAARS1997-06-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A040099-001NORCO325MG;5MGTABLET / ORALAARS1997-06-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040099-001NORCO325MG;5MGTABLET / ORAL1997-06-25f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A040099-001AA174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040099-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040099-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040099-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040099-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040099-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040099-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040099-001AA1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

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

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, Related label table
NDCRelated label
12634-264-00Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-40Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-50Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-57Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-59Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-61Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-64Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-65Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-66Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-71Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-80Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-82Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-85Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-91Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-92Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-94Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-95Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only
12634-264-96Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg C-II Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-264-00HYDROCODONE BITARTRATE AND ACETAMINOPHEN10 in 1 BOTTLETABLET107
12634-264-40HYDROCODONE BITARTRATE AND ACETAMINOPHEN40 in 1 BOTTLE, PLASTICTABLET407
12634-264-50HYDROCODONE BITARTRATE AND ACETAMINOPHEN50 in 1 BOTTLE, PLASTICTABLET507
12634-264-57HYDROCODONE BITARTRATE AND ACETAMINOPHEN20 in 1 BLISTER PACKTABLET207
12634-264-59HYDROCODONE BITARTRATE AND ACETAMINOPHEN30 in 1 BLISTER PACKTABLET307
12634-264-61HYDROCODONE BITARTRATE AND ACETAMINOPHEN10 in 1 BLISTER PACKTABLET107
12634-264-64HYDROCODONE BITARTRATE AND ACETAMINOPHEN4 in 1 BLISTER PACKTABLET47
12634-264-65HYDROCODONE BITARTRATE AND ACETAMINOPHEN5 in 1 BLISTER PACKTABLET57
12634-264-66HYDROCODONE BITARTRATE AND ACETAMINOPHEN6 in 1 BLISTER PACKTABLET67
12634-264-71HYDROCODONE BITARTRATE AND ACETAMINOPHEN30 in 1 BOTTLETABLET307
12634-264-80HYDROCODONE BITARTRATE AND ACETAMINOPHEN20 in 1 BOTTLETABLET207
12634-264-82HYDROCODONE BITARTRATE AND ACETAMINOPHEN12 in 1 BOTTLE, PLASTICTABLET127
12634-264-85HYDROCODONE BITARTRATE AND ACETAMINOPHEN15 in 1 BOTTLETABLET157
12634-264-91HYDROCODONE BITARTRATE AND ACETAMINOPHEN1 in 1 BLISTER PACKTABLET17
12634-264-92HYDROCODONE BITARTRATE AND ACETAMINOPHEN2 in 1 BOTTLE, PLASTICTABLET27
12634-264-94HYDROCODONE BITARTRATE AND ACETAMINOPHEN4 in 1 BOTTLE, PLASTICTABLET47
12634-264-95HYDROCODONE BITARTRATE AND ACETAMINOPHEN5 in 1 BOTTLE, PLASTICTABLET57
12634-264-96HYDROCODONE BITARTRATE AND ACETAMINOPHEN6 in 1 BOTTLE, PLASTICTABLET67

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EHYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHYDROCODONE BITARTRATE WITH ACETAMINOPHEN TABLET [APOTHECA INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-264HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [APOTHECA INC.]7Legacy NDC, 18 package rows20160618_2ec4d6a5-d2a3-4c91-9d61-afeb3abd17af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN2ec4d6a5-d2a3-4c91-9d61-afeb3abd17af7
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD2ec4d6a5-d2a3-4c91-9d61-afeb3abd17af7
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY2ec4d6a5-d2a3-4c91-9d61-afeb3abd17af7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-264-001263402640010 in 1 BOTTLEHistorical
12634-264-401263402644040 in 1 BOTTLE, PLASTICHistorical
12634-264-501263402645050 in 1 BOTTLE, PLASTICHistorical
12634-264-571263402645720 in 1 BLISTER PACKHistorical
12634-264-591263402645930 in 1 BLISTER PACKHistorical
12634-264-611263402646110 in 1 BLISTER PACKHistorical
12634-264-64126340264644 in 1 BLISTER PACKHistorical
12634-264-65126340264655 in 1 BLISTER PACKHistorical
12634-264-66126340264666 in 1 BLISTER PACKHistorical
12634-264-711263402647130 in 1 BOTTLEHistorical
12634-264-801263402648020 in 1 BOTTLEHistorical
12634-264-821263402648212 in 1 BOTTLE, PLASTICHistorical
12634-264-851263402648515 in 1 BOTTLEHistorical
12634-264-91126340264911 in 1 BLISTER PACKHistorical
12634-264-92126340264922 in 1 BOTTLE, PLASTICHistorical
12634-264-94126340264944 in 1 BOTTLE, PLASTICHistorical
12634-264-95126340264955 in 1 BOTTLE, PLASTICHistorical
12634-264-96126340264966 in 1 BOTTLE, PLASTICHistorical