Home NDC 17856-3728-1 Propranolol Hydrochloride
Product NDC 17856-3728
Requested package NDC 17856-3728-1
11-digit product format 178563728
Labeler code 17856
Product ID 17856-3728_35d2e40e-8f0d-ef2d-e063-6294a90aadc0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Propranolol Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application ANDA070979
Marketing category ANDA
Marketing start 1987-05-15
Substance PROPRANOLOL HYDROCHLORIDE
Active strength 20 mg/5mL
Pharmacologic classes Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog .
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.
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 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A070979-001 PROPRANOLOL HYDROCHLORIDE 20MG/5ML SOLUTION / ORAL RS 1987-05-15 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Propranolol Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROPRANOLOL HYDROCHLORIDE 20 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F8A3652H1V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 856724 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 17856-3728-1 Propranolol Hydrochloride 5 mL in 1 CUP SOLUTION 5 5 17856-3728-1 Propranolol Hydrochloride 72 in 1 CASE SOLUTION 72 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-3728 PROPRANOLOL HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.] 5 Current NDC, Legacy NDC, 2 package rows 20250525_b609cc7c-1f6a-452b-8ada-c4d2989b83dc.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 · 3 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 17856-3728-1 17856372801 72 CUP in 1 CASE (17856-3728-1) / 5 mL in 1 CUP 72 cup 2024-05-10 0000-00-00 No No Current