FDA.reportPublic FDA data

Hydrocodone Bitartrate and Acetaminophen

Product NDC
64850-630
11-digit product format
648500630
Labeler code
64850
Product ID
64850-630_91acad07-a9ce-450e-b9f6-4401b89bd32c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Elite Laboratories, Inc.
Application
ANDA209924
Marketing category
ANDA
Marketing start
2018-11-16
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 2.5 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209924-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;2.5MGTABLET / ORALAA2018-11-16
A209924-002HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;5MGTABLET / ORALAA2018-11-16
A209924-003HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;7.5MGTABLET / ORALAA2018-11-16
A209924-004HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG;10MGTABLET / ORALAA2018-11-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A209924-001AA
A209924-002AA
A209924-003AA
A209924-004AA

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 22:54:322026-06A209924-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;2.5MGTABLET / ORALAA2018-11-16a50c72e98297…
2026-08-01 22:54:322026-06A209924-002HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;5MGTABLET / ORALAA2018-11-16a50c72e98297…
2026-08-01 22:54:322026-06A209924-003HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;7.5MGTABLET / ORALAA2018-11-16a50c72e98297…
2026-08-01 22:54:322026-06A209924-004HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG;10MGTABLET / ORALAA2018-11-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209924-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A209924-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A209924-003AA1a50c72e98297…
2026-08-01 22:54:322026-06A209924-004AA1a50c72e98297…

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENElite Laboratories, Inc.89b8145f-5310-4b58-a65d-586dc90d642d2025-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209924
application number: ANDA209924
ndc (product): 64850-630

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 BITARTRATE325 mg/1
ACETAMINOPHEN2.5 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856999Internal RxNorm lookup
857002Internal RxNorm lookup
857005Internal RxNorm lookup
857391Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
89b8145f-5310-4b58-a65d-586dc90d642dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
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
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
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64850-630-01Hydrocodone Bitartrate and Acetaminophen100 in 1 BOTTLE, PLASTICTABLET10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64850-630-01EA - Each64850-63089bc1641-3bf2-436a-8b08-c4c526aea6ae12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64850-630HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [ELITE LABORATORIES, INC.]8Current NDC, Legacy NDC, 1 package rows20240831_89b8145f-5310-4b58-a65d-586dc90d642d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856999HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral TabletPSN89b8145f-5310-4b58-a65d-586dc90d642d10
857391HYDROcodone bitartrate 2.5 MG / acetaminophen 325 MG Oral TabletPSN89b8145f-5310-4b58-a65d-586dc90d642d10
857002HYDROcodone bitartrate 5 MG / acetaminophen 325 MG Oral TabletPSN89b8145f-5310-4b58-a65d-586dc90d642d10
857005HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG Oral TabletPSN89b8145f-5310-4b58-a65d-586dc90d642d10
856999acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral TabletSCD89b8145f-5310-4b58-a65d-586dc90d642d10
857391acetaminophen 325 MG / hydrocodone bitartrate 2.5 MG Oral TabletSCD89b8145f-5310-4b58-a65d-586dc90d642d10
857002acetaminophen 325 MG / hydrocodone bitartrate 5 MG Oral TabletSCD89b8145f-5310-4b58-a65d-586dc90d642d10
857005acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSCD89b8145f-5310-4b58-a65d-586dc90d642d10
856999APAP 325 MG / hydrocodone bitartrate 10 MG Oral TabletSY89b8145f-5310-4b58-a65d-586dc90d642d10
857391APAP 325 MG / Hydrocodone Bitartrate 2.5 MG Oral TabletSY89b8145f-5310-4b58-a65d-586dc90d642d10
857002APAP 325 MG / hydrocodone bitartrate 5 MG Oral TabletSY89b8145f-5310-4b58-a65d-586dc90d642d10
857005APAP 325 MG / hydrocodone bitartrate 7.5 MG Oral TabletSY89b8145f-5310-4b58-a65d-586dc90d642d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64850-630-0164850063001100 TABLET in 1 BOTTLE, PLASTIC (64850-630-01) 100 tablet2018-11-16NoNoCurrent