FDA.reportPublic FDA data

Butalbital and Acetaminophen

Product NDC
68682-306
11-digit product format
686820306
Labeler code
68682
Product ID
68682-306_3f21cb4d-0b19-441c-a6df-2c3077e1fede
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital and Acetaminophen tablets
Dosage form
TABLET
Route
ORAL
Labeler
Oceanside Pharmaceuticals
Application
ANDA090956
Marketing category
ANDA
Marketing start
2017-06-19
Substance
ACETAMINOPHEN; BUTALBITAL
Active strength
300; 50 mg/1; mg/1
Pharmacologic classes
Barbiturate [EPC], Barbiturates [CS]
DEA schedule
CIII
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090956-001BUTALBITAL AND ACETAMINOPHENACETAMINOPHEN; BUTALBITAL300MG;50MGTABLET / ORALAARS2011-08-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090956-001AA

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 22:54:322026-06A090956-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGTABLET / ORALAARS2011-08-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090956-001AA1a50c72e98297…

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
Butalbital and AcetaminophenBUTALBITAL AND ACETAMINOPHEN TABLETSOceanside Pharmaceuticalsd2213ffd-18f6-45f5-9af7-690a977562c42020-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090956
application number: ANDA090956
ndc (product): 68682-306

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUTALBITAL300 mg/1
ACETAMINOPHEN50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KHS0AZ4JVKInternal 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
1249617Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d2213ffd-18f6-45f5-9af7-690a977562c4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68682-306-01Butalbital and Acetaminophen100 in 1 BOTTLE, PLASTICTABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-306-01EA - Each68682-306c1584a30-f119-43d6-aff1-5535c227233412017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-306BUTALBITAL AND ACETAMINOPHEN (BUTALBITAL AND ACETAMINOPHEN TABLETS) TABLET [OCEANSIDE PHARMACEUTICALS]4Current NDC, Legacy NDC, 1 package rows20210710_d2213ffd-18f6-45f5-9af7-690a977562c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1249617butalbital 50 MG / acetaminophen 300 MG Oral TabletPSNd2213ffd-18f6-45f5-9af7-690a977562c44
1249617acetaminophen 300 MG / butalbital 50 MG Oral TabletSCDd2213ffd-18f6-45f5-9af7-690a977562c44
1249617APAP 300 MG / butalbital 50 MG Oral TabletSYd2213ffd-18f6-45f5-9af7-690a977562c44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68682-306-0168682030601100 TABLET in 1 BOTTLE, PLASTIC (68682-306-01) 100 tablet2017-06-190000-00-00NoNoCurrent