Ascomp with Codeine

Product NDC
79739-6094
11-digit product format
797396094
Labeler code
79739
Product ID
79739-6094_e8714e9d-80cc-4c5e-b469-67ce10256d85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Aspirin, Cafeine, and Codeine Phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
LGM PHARMA SOLUTIONS, LLC
Application
ANDA075231
Marketing category
ANDA
Marketing start
2001-11-30
Substance
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Active strength
325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 1 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct79739-6094IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage79739-609479739-6094-1IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATEASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075231-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-303f01610625f2…
2019-09-15 20:21 UTC2019-09A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075231-001BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2001-11-30e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075231-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075231-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075231-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075231-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075231-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075231-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075231-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075231-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075231-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075231-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075231-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075231-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075231-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075231-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075231-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075231-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075231-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075231-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075231-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075231-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075231-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075231-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075231-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075231-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075231-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075231-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075231-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075231-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075231-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075231-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075231-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075231-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075231-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075231-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075231-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075231-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075231-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075231-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075231-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075231-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Ascomp with Codeine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUTALBITAL325 mg/1
ASPIRIN50 mg/1
CAFFEINE40 mg/1
CODEINE PHOSPHATE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KHS0AZ4JVKInternal UNII lookup
R16CO5Y76EInternal UNII lookup
3G6A5W338EInternal UNII lookup
GSL05Y1MN6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
994237Internal RxNorm lookup
994239Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1cab3106-1064-4b42-892b-39f405d9e02fAvailable 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
e9576821-a971-5261-628e-82ad9e10acdbProduct name220150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-04-17These highlights do not include all the information needed to use Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP safely and effectively. See full prescribing information for Butalbital, Aspirin, Caffe i ne, and Codeine Phosphate Capsules, USP . B utalbital, A spirin, C affeine, and C odeine P hosphate C apsules, USP for oral use, CIII Initial U.S. Approval: 1990
2024-04-17These highlights do not include all the information needed to use Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP safely and effectively. See full prescribing information for Butalbital, Aspirin, Caffe i ne, and Codeine Phosphate Capsules, USP . B utalbital, A spirin, C affeine, and C odeine P hosphate C apsules, USP for oral use, CIII Initial U.S. Approval: 1990
2024-01-30These highlights do not include all the information needed to use Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP safely and effectively. See full prescribing information for Butalbital, Aspirin, Caffe i ne, and Codeine Phosphate Capsules, USP . B utalbital, A spirin, C affeine, and C odeine P hosphate C apsules, USP for oral use, CIII Initial U.S. Approval: 1990
2024-01-30These highlights do not include all the information needed to use Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP safely and effectively. See full prescribing information for Butalbital, Aspirin, Caffe i ne, and Codeine Phosphate Capsules, USP . B utalbital, A spirin, C affeine, and C odeine P hosphate C apsules, USP for oral use, CIII Initial U.S. Approval: 1990

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79739-6094-1Ascomp with Codeine100 in 1 BOTTLECAPSULE10015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79739-6094ASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFEINE, AND CODEINE PHOSPHATE) CAPSULE [LGM PHARMA SOLUTIONS, LLC]13Current NDC, Legacy NDC, 1 package rows20241018_1cab3106-1064-4b42-892b-39f405d9e02f.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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATEBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATEBryant Ranch Prepack95a33c9b-79a6-47c7-8433-fc217950b88f2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075231
application number: ANDA075231
Ascomp with CodeineBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATEBreckenridge Pharmaceutical, Inc.243a6aea-0f48-42a9-a85e-ff247ab943362026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075231
application number: ANDA075231
Ascomp with CodeineBUTALBITAL, ASPIRIN, CAFEINE, AND CODEINE PHOSPHATELGM PHARMA SOLUTIONS, LLC1cab3106-1064-4b42-892b-39f405d9e02f2025-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075231
application number: ANDA075231
ndc (product): 79739-6094

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994239Ascomp with Codeine 50 MG / 325 MG / 40 MG / 30 MG Oral CapsulePSN1cab3106-1064-4b42-892b-39f405d9e02f15
994237butalbital 50 MG / aspirin 325 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsulePSN1cab3106-1064-4b42-892b-39f405d9e02f15
994239aspirin 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule [Ascomp]SBD1cab3106-1064-4b42-892b-39f405d9e02f15
994237aspirin 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsuleSCD1cab3106-1064-4b42-892b-39f405d9e02f15
994237ASA 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsuleSY1cab3106-1064-4b42-892b-39f405d9e02f15
994239ASA 325 MG / butalbital 50 MG / Caffeine 40 MG / Codeine Phosphate 30 MG Oral Capsule [Ascomp]SY1cab3106-1064-4b42-892b-39f405d9e02f15
994239Ascomp with Codeine (ASA 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG) Oral CapsuleSY1cab3106-1064-4b42-892b-39f405d9e02f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79739-6094-179739609401100 CAPSULE in 1 BOTTLE (79739-6094-1) 100 capsule2020-07-240000-00-00NoNoCurrent