Home NDC 24979-133 Terbutaline Sulfate
Product NDC 24979-133
11-digit product format 249790133
Labeler code 24979
Product ID 24979-133_3fd94b35-ef5a-4eb3-a3bd-0ce7572521d6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Terbutaline Sulfate
Dosage form TABLET
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA211832
Marketing category ANDA
Marketing start 2020-07-13
Substance TERBUTALINE SULFATE
Active strength 5 mg/1
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211832-001 TERBUTALINE SULFATE TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2020-06-19 A211832-002 TERBUTALINE SULFATE TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2020-06-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 74 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 2026-02-19 14:30 UTC 2026-02 A211832-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2020-06-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211832-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2020-06-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211832-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2020-06-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211832-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2020-06-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211832-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2020-06-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211832-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2020-06-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211832-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2020-06-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211832-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2020-06-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211832-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2020-06-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211832-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2020-06-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211832-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2020-06-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211832-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2020-06-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211832-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2020-06-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211832-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2020-06-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211832-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2020-06-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211832-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2020-06-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211832-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2020-06-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211832-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2020-06-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211832-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2020-06-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211832-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2020-06-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211832-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2020-06-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211832-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2020-06-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211832-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2020-06-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211832-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2020-06-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211832-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2020-06-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211832-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2020-06-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211832-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2020-06-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211832-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2020-06-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211832-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2020-06-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211832-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2020-06-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211832-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2020-06-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211832-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2020-06-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211832-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2020-06-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211832-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2020-06-19 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211832-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2020-06-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211832-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2020-06-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211832-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2020-06-19 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211832-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2020-06-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211832-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2020-06-19 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211832-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB 2020-06-19 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Terbutaline Sulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TERBUTALINE SULFATE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 576PU70Y8E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857677 Internal RxNorm lookup 857683 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 24979-133-01 Terbutaline Sulfate 100 in 1 BOTTLE TABLET 100 4 24979-133-03 Terbutaline Sulfate 1000 in 1 BOTTLE TABLET 1000 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24979-133 TERBUTALINE SULFATE TABLET [TWI PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20231202_3a4e5046-293c-4616-8679-6da65f31626b.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 24979-133-01 24979013301 100 TABLET in 1 BOTTLE (24979-133-01) 100 tablet 2020-07-13 0000-00-00 No No Current 24979-133-03 24979013303 1000 TABLET in 1 BOTTLE (24979-133-03) 1000 tablet 2020-07-13 0000-00-00 No No Current