FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
27808-116
Requested package NDC
27808-116-01
11-digit product format
278080116
Labeler code
27808
Product ID
27808-116_b87bebc7-651b-4b88-8921-cfddb4265559
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
2016-04-07
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
300; 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

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202214-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORALAA2013-03-27
A202214-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;7.5MGTABLET / ORALAA2013-03-27
A202214-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;10MGTABLET / ORALAA2013-03-27
A202214-004HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE300MG;5MGTABLET / ORALAA2016-03-15
A202214-005HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE300MG;7.5MGTABLET / ORALAA2016-03-15
A202214-006HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE300MG;10MGTABLET / ORALAA2016-03-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A202214-001AA
A202214-002AA
A202214-003AA
A202214-004AA
A202214-005AA
A202214-006AA

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202214-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202214-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202214-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202214-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2016-03-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202214-005HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2016-03-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202214-006HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2016-03-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2016-03-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-005HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2016-03-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-006HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2016-03-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A202214-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202214-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202214-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202214-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2016-03-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202214-005HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2016-03-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202214-006HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2016-03-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202214-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202214-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202214-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202214-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2016-03-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202214-005HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2016-03-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202214-006HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2016-03-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202214-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202214-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202214-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202214-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2016-03-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202214-005HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2016-03-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202214-006HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2016-03-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202214-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202214-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202214-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202214-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2016-03-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202214-005HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2016-03-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202214-006HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2016-03-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202214-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202214-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202214-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202214-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2016-03-152680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202214-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202214-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202214-003AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202214-004AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202214-005AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202214-006AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-003AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-004AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-005AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202214-006AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202214-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202214-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202214-003AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202214-004AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202214-005AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202214-006AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202214-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202214-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202214-003AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202214-004AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202214-005AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202214-006AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202214-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202214-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202214-003AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202214-004AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202214-005AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202214-006AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202214-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202214-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202214-003AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202214-004AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202214-005AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202214-006AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202214-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202214-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202214-003AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202214-004AA12680178bc6a6…

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
ACETAMINOPHEN10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NO70W886KKInternal UNII lookup
362O9ITL9DInternal 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
d8fe4ae4-bd19-42eb-b74d-f302b3f914eeAvailable 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
27808-116-01Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLE, PLASTICTABLET10030
27808-116-02Hydrocodone Bitartrate and Acetaminophen500 in 1 BOTTLETABLET50030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27808-116-01EA - Each27808-116194c1cf2-cc26-488a-b6df-90fcea8f809812016-06-14
27808-116-02EA - Each27808-11658a4acbf-2a2c-4c4a-9838-d647d7d99a7c12016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27808-116HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [CRANBURY PHARMACEUTICALS, LLC]26Current NDC, Legacy NDC, 2 package rows20250130_d8fe4ae4-bd19-42eb-b74d-f302b3f914ee.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 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy425258b6-72d7-e9b5-e063-6394a90a3fc72026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy4135fb50-2e77-7365-e063-6294a90a8c432026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack375c3f81-3276-431e-8773-7b189730e9fd2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENST. MARY'S MEDICAL PARK PHARMACY3d347b9b-1b5c-68c8-e063-6294a90aaa9b2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack8e99994a-83b4-4b1f-9654-4ae373bf2c4d2026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack5a7fb0e7-eb06-4332-a786-d0051afd1dd92026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack679b4f87-59df-48d4-a9e6-e78aaeab23ea2026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackd3b7f2b3-28c4-4ba5-961f-48e838600be22026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack092f4694-98df-41bd-b37c-afbcda087e562026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepacka3cbf0c1-b589-4e4a-b355-01bddb7e49552026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackf7b554ab-2996-4cf0-a498-01cd5ef5df4f2026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack5431c1bf-469b-4944-a558-52d098c9b0f02026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepacke5d6de20-c195-4b97-963a-2f3832e50b492026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack6fae7c90-1d80-4eb8-bbb8-8f945884f5c62026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack806a981f-85ff-4e58-8ff0-7ab02ed2e5c12026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENCranbury Pharmaceuticals, LLCd8fe4ae4-bd19-42eb-b74d-f302b3f914ee2025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
ndc (package): 27808-116-01
ndc (product): 27808-116
ndc11 (package): 27808011601
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENCranbury Pharmaceuticals, LLCd4caec6d-4af2-4f1c-9add-c0c948b83b162025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack36bf5e37-9202-4288-8354-9d123fb692d32025-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepackfa88d7b2-6c8e-4893-bd81-ecd4f2aca4932025-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENAsclemed USA, Inc.ba7d27eb-952d-4e99-95b9-5b0b2f85794b2025-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202214
application number: ANDA202214

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856980HYDROcodone bitartrate 10 MG / acetaminophen 300 MG Oral TabletPSN3aa038f9-f837-466f-aa3c-68a7bd0b2388105
856980acetaminophen 300 MG / hydrocodone bitartrate 10 MG Oral TabletSCD3aa038f9-f837-466f-aa3c-68a7bd0b2388105
856980APAP 300 MG / hydrocodone bitartrate 10 MG Oral TabletSY3aa038f9-f837-466f-aa3c-68a7bd0b2388105
856980HYDROcodone bitartrate 10 MG / acetaminophen 300 MG Oral TabletPSNe5d6de20-c195-4b97-963a-2f3832e50b49103
856980acetaminophen 300 MG / hydrocodone bitartrate 10 MG Oral TabletSCDe5d6de20-c195-4b97-963a-2f3832e50b49103
856980APAP 300 MG / hydrocodone bitartrate 10 MG Oral TabletSYe5d6de20-c195-4b97-963a-2f3832e50b49103
856980HYDROcodone bitartrate 10 MG / acetaminophen 300 MG Oral TabletPSNd8fe4ae4-bd19-42eb-b74d-f302b3f914ee30
856987HYDROcodone bitartrate 5 MG / acetaminophen 300 MG Oral TabletPSNd8fe4ae4-bd19-42eb-b74d-f302b3f914ee30
856992HYDROcodone bitartrate 7.5 MG / acetaminophen 300 MG Oral TabletPSNd8fe4ae4-bd19-42eb-b74d-f302b3f914ee30
856980acetaminophen 300 MG / hydrocodone bitartrate 10 MG Oral TabletSCDd8fe4ae4-bd19-42eb-b74d-f302b3f914ee30
856987acetaminophen 300 MG / hydrocodone bitartrate 5 MG Oral TabletSCDd8fe4ae4-bd19-42eb-b74d-f302b3f914ee30
856992acetaminophen 300 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCDd8fe4ae4-bd19-42eb-b74d-f302b3f914ee30
856980APAP 300 MG / hydrocodone bitartrate 10 MG Oral TabletSYd8fe4ae4-bd19-42eb-b74d-f302b3f914ee30
856987APAP 300 MG / hydrocodone bitartrate 5 MG Oral TabletSYd8fe4ae4-bd19-42eb-b74d-f302b3f914ee30
856992APAP 300 MG / Hydrocodone Bitartrate 7.5 MG Oral TabletSYd8fe4ae4-bd19-42eb-b74d-f302b3f914ee30

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27808-116-0127808011601100 TABLET in 1 BOTTLE, PLASTIC (27808-116-01) 100 tablet2016-04-070000-00-00NoNoCurrent