FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
60760-692
Requested package NDC
60760-692-60
11-digit product format
607600692
Labeler code
60760
Product ID
60760-692_522ef075-73ea-38e2-e063-6294a90aa20e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA202214
Marketing category
ANDA
Marketing start
2014-10-06
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 7.5 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202214-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2013-03-27a50c72e98297…
2026-08-01 22:54:322026-06A202214-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2013-03-27a50c72e98297…
2026-08-01 22:54:322026-06A202214-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2013-03-27a50c72e98297…
2026-08-01 22:54:322026-06A202214-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;5MGTABLET / ORALAA2016-03-15a50c72e98297…
2026-08-01 22:54:322026-06A202214-005HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;7.5MGTABLET / ORALAA2016-03-15a50c72e98297…
2026-08-01 22:54:322026-06A202214-006HYDROCODONE BITARTRATE AND ACETAMINOPHEN300MG;10MGTABLET / ORALAA2016-03-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202214-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A202214-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A202214-003AA1a50c72e98297…
2026-08-01 22:54:322026-06A202214-004AA1a50c72e98297…
2026-08-01 22:54:322026-06A202214-005AA1a50c72e98297…
2026-08-01 22:54:322026-06A202214-006AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (package): 60760-692-60
ndc (product): 60760-692
ndc11 (package): 60760069260
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
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

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocodone Bitartrate and Acetaminophen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCODONE BITARTRATE325 mg/1
ACETAMINOPHEN7.5 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
857005Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3d347b9b-1b5c-68c8-e063-6294a90aaa9bAvailable 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
60760-692-30Hydrocodone Bitartrate and Acetaminophen30 in 1 BOTTLE, PLASTICTABLET303
60760-692-60Hydrocodone Bitartrate and Acetaminophen60 in 1 BOTTLE, PLASTICTABLET603
60760-692-90Hydrocodone Bitartrate and Acetaminophen90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-692-30EA - Each60760-692959538a0-a5b6-4396-a5d9-dca2eaeacb9612025-10-14
60760-692-60EA - Each60760-6928ad23d94-6f09-48be-995c-1c1a12879ddd12025-10-14
60760-692-90EA - Each60760-6926b744a62-8bd0-461d-a6bc-d937678e969b12025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN3d347b9b-1b5c-68c8-e063-6294a90aaa9b3
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD3d347b9b-1b5c-68c8-e063-6294a90aaa9b3
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY3d347b9b-1b5c-68c8-e063-6294a90aaa9b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-692-606076006926060 TABLET in 1 BOTTLE, PLASTIC (60760-692-60) 60 tablet2025-08-22NoNoCurrent