Home NDC 63323-665 Terbutaline Sulfate
Product NDC 63323-665
11-digit product format 633230665
Labeler code 63323
Product ID 63323-665_15846c75-dc60-4339-b97b-5c9d78d66cf1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TERBUTALINE SULFATE
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA076887
Marketing category ANDA
Marketing start 2011-03-10
Substance TERBUTALINE SULFATE
Active strength 1 mg/mL
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 A076887-001 TERBUTALINE SULFATE TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076887-001 AP
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 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076887-001 TERBUTALINE SULFATE 1MG/ML INJECTABLE / INJECTION AP 2004-05-26 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 Terbutaline Sulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TERBUTALINE SULFATE 1 mg/mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857635 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 63323-665-00 Terbutaline Sulfate 1 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 1 4 63323-665-01 Terbutaline Sulfate 25 in 1 TRAY INJECTION, SOLUTION 25 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Terbutaline Sulfate ACTIVE INGREDIENT 576PU70Y8E TERBUTALINE SULFATE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] 1 TERBUTALINE SULFATE ACTIVE INGREDIENT 576PU70Y8E TERBUTALINE SULFATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 Terbutaline ACTIVE MOIETY N8ONU3L3PG TERBUTALINE SULFATE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] 1 TERBUTALINE ACTIVE MOIETY N8ONU3L3PG TERBUTALINE SULFATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB TERBUTALINE SULFATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X TERBUTALINE SULFATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-665 TERBUTALINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20220808_cec31032-f366-4524-9e01-63146e473b2b.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 63323-665-00 63323066500 1 mL in 1 VIAL, SINGLE-USE 1 ml Historical 63323-665-01 63323066501 25 VIAL, SINGLE-USE in 1 TRAY (63323-665-01) / 1 mL in 1 VIAL, SINGLE-USE (63323-665-00) 2011-03-10 0000-00-00 No No Current