Home NDC 62135-525 Terbutaline Sulfate
Product NDC 62135-525
11-digit product format 621350525
Labeler code 62135
Product ID 62135-525_459ef32e-2348-14bd-e063-6394a90a6a90
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Terbutaline Sulfate
Dosage form TABLET
Route ORAL
Labeler Chartwell RX, LLC.
Application ANDA077152
Marketing category ANDA
Marketing start 2005-03-25
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 42 .
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 A077152-001 TERBUTALINE SULFATE TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 A077152-002 TERBUTALINE SULFATE TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25
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 3 · 84 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 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077152-001 TERBUTALINE SULFATE 2.5MG TABLET / ORAL AB 2005-03-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077152-002 TERBUTALINE SULFATE 5MG TABLET / ORAL AB RS 2005-03-25 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62135-525-90 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 62135-525 TERBUTALINE SULFATE TABLET [CHARTWELL RX, LLC.] 1 Current NDC, 1 package rows 20230306_859267c6-3d14-4123-9b9d-4fc248f09726.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 Sample Exclude flag Status 62135-525-90 62135052590 90 TABLET in 1 BOTTLE (62135-525-90) 90 tablet 2023-02-28 No No Current