Home NDC 11584-0030 Tencon
Product NDC 11584-0030
11-digit product format 115840030
Labeler code 11584
Product ID 11584-0030_18834fb3-9eae-0e94-e063-6394a90accfb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name butalbital and acetaminophen
Dosage form TABLET
Route ORAL
Labeler El Dorado Distributors LLC
Application ANDA089987
Marketing category ANDA
Marketing start 2013-10-10
Substance ACETAMINOPHEN; BUTALBITAL
Active strength 325; 50 mg/1; mg/1
Pharmacologic classes Barbiturate [EPC], Barbiturates [CS]
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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A089987-001 BUTAPAP ACETAMINOPHEN; BUTALBITAL 325MG;50MG TABLET / ORAL AA RS 1992-10-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A089987-001 AA
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089987-001 BUTAPAP 325MG;50MG TABLET / ORAL AA RS 1992-10-26 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tencon
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUTALBITAL 325 mg/1 ACETAMINOPHEN 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination KHS0AZ4JVK Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197426 Internal RxNorm lookup 1483329 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11584-0030-1 Tencon 100 in 1 BOTTLE, PLASTIC TABLET 100 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [INTERNATIONAL ETHICAL LABS, INC.] 1 BUTALBITAL ACTIVE INGREDIENT KHS0AZ4JVK TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [INTERNATIONAL ETHICAL LABS, INC.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [INTERNATIONAL ETHICAL LABS, INC.] 1 BUTALBITAL ACTIVE MOIETY KHS0AZ4JVK TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [INTERNATIONAL ETHICAL LABS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [INTERNATIONAL ETHICAL LABS, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [INTERNATIONAL ETHICAL LABS, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [INTERNATIONAL ETHICAL LABS, INC.] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [INTERNATIONAL ETHICAL LABS, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [INTERNATIONAL ETHICAL LABS, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [INTERNATIONAL ETHICAL LABS, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [INTERNATIONAL ETHICAL LABS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11584-0030 TENCON (BUTALBITAL AND ACETAMINOPHEN) TABLET [EL DORADO DISTRIBUTORS LLC] 6 Current NDC, Legacy NDC, 1 package rows 20240517_4e4a9925-67aa-4be7-8bb7-c8b058ffe223.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 11584-0030-1 11584003001 100 TABLET in 1 BOTTLE, PLASTIC (11584-0030-1) 100 tablet 2013-10-10 0000-00-00 No No Current