Polyethylene Glycol 3350
- Product NDC
- 17856-0962
- Requested package NDC
- 17856-0962-3
- 11-digit product format
- 178560962
- Labeler code
- 17856
- Product ID
- 17856-0962_47096646-6119-4f5d-8b50-d58c4401a4fd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- polyethylene glycol 3350
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- ATLANTIC BIOLOGICALS CORP.
- Application
- ANDA090812
- Marketing category
- ANDA
- Marketing start
- 2019-03-27
- Marketing end
- 0000-00-00
- Substance
- POLYETHYLENE GLYCOL 3350
- Active strength
- 17 g/17g
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 17856-0962 | 17856-0962-3 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090812-001 | POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A090812-001 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION / ORAL | 2009-10-07 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| EasyLAX | POLYETHYLENE GLYCOL 3350 | VALU MERCHANDISERS COMPANY | 6597811b-6471-5afd-e053-2991aa0a07c2 | 2025-12-16 | Warnings | 090812 ANDA090812 |
| CLEARLAX | POLYETHYLENE GLYCOL 3350 | STRATEGIC SOURCING SERVICES LLC | 041157b8-476c-e7d2-e063-6394a90ac3a0 | 2025-06-11 | Warnings | 090812 ANDA090812 |
| Polyethylene Glycol 3350, NF Powder for Solution, Laxative | POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE | Pharmaceutica North America, Inc. | d048111f-8144-4d51-a0c2-a967b2bce455 | 2025-03-04 | Warnings | 090812 ANDA090812 |
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | Bryant Ranch Prepack | 66276671-0ccd-4c32-a697-31e679fce0e3 | 2024-02-06 | Warnings | 090812 ANDA090812 |
| Polyethylene Glycol 3350, NF Powder for Solution, Laxative | POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE | LGM PHARMA SOLUTIONS, LLC | d78bead5-ff19-4d45-9003-ec131f1f5a13 | 2024-01-17 | Warnings | 090812 ANDA090812 |
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | Geri-Care Pharmaceutical Corp | f4c7eb80-d8d5-406d-90d0-9d17914d71f2 | 2022-11-24 | Warnings | 090812 ANDA090812 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17856-0962-1 | EA - Each | 17856-0962 | 6ce26531-ef46-4e0a-a50d-64d078092554 | 1 | 2021-09-07 |
| 17856-0962-2 | EA - Each | 17856-0962 | aa213cf6-523a-4e76-876a-2cf5f4e8fc84 | 1 | 2021-09-07 |
| 17856-0962-3 | EA - Each | 17856-0962 | 34e075a0-8703-41fe-b2d8-1fc08ba1dcc3 | 1 | 2021-09-07 |
| 17856-0962-4 | EA - Each | 17856-0962 | 0cac435c-32af-4c8c-b09d-98bd58dc5daf | 1 | 2021-09-07 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 17856-0962-3 | 17856096203 | 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0962-3) > 8.5 g in 1 CUP, UNIT-DOSE | 2021-02-17 | 0000-00-00 | No | No | Current |