Home NDC 71205-938 Terbutaline Sulfate
Product NDC 71205-938
11-digit product format 712050938
Labeler code 71205
Product ID 71205-938_9f8ee6b8-61e1-478a-90de-57358fdb5905
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Terbutaline Sulfate
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application ANDA211832
Marketing category ANDA
Marketing start 2020-07-13
Substance TERBUTALINE SULFATE
Active strength 2.5 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 2.5 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71205-938-00 Terbutaline Sulfate 100 in 1 BOTTLE TABLET 100 2 71205-938-30 Terbutaline Sulfate 30 in 1 BOTTLE TABLET 30 2 71205-938-55 Terbutaline Sulfate 500 in 1 BOTTLE TABLET 500 2 71205-938-60 Terbutaline Sulfate 60 in 1 BOTTLE TABLET 60 2 71205-938-90 Terbutaline Sulfate 90 in 1 BOTTLE TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-938 TERBUTALINE SULFATE TABLET [PROFICIENT RX LP] 2 Current NDC, Legacy NDC, 5 package rows 20220426_0a95bc4f-34d3-4b5e-841b-6839e1c1e0c7.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 71205-938-00 71205093800 100 TABLET in 1 BOTTLE (71205-938-00) 100 tablet 2020-11-19 0000-00-00 No No Current 71205-938-30 71205093830 30 TABLET in 1 BOTTLE (71205-938-30) 30 tablet 2020-11-19 0000-00-00 No No Current 71205-938-55 71205093855 500 TABLET in 1 BOTTLE (71205-938-55) 500 tablet 2020-11-19 0000-00-00 No No Current 71205-938-60 71205093860 60 TABLET in 1 BOTTLE (71205-938-60) 60 tablet 2020-11-19 0000-00-00 No No Current 71205-938-90 71205093890 90 TABLET in 1 BOTTLE (71205-938-90) 90 tablet 2020-11-19 0000-00-00 No No Current