Prescription drug · ANDA
Ethambutol Hydrochloride NDC 70518-3662
Ethambutol hydrochloride 100 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3662-1 | 7051836620170518366201 | 50 POUCH in 1 BOX (70518-3662-1) / 1 TABLET in 1 POUCH (70518-3662-2)Marketed from Apr 23, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ethambutol Hydrochloride
- Generic name (nonproprietary)
- ethambutol hydrochloride
- Active ingredients
- Ethambutol hydrochloride — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078939
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-3662_5db7b2b9-48ae-6a85-e063-6294a90a0d50SPL ID 5db7b2b9-48ae-6a85-e063-6294a90a0d50
- Pharmacologic class
- Antimycobacterial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470518366201followed by a unit qualifier and the quantityPackage 70518-3662-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70518-3662
- What is NDC 70518-3662?
- 70518-3662 is the product NDC for Ethambutol Hydrochloride, Ethambutol hydrochloride 100 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ethambutol Hydrochloride.
- What is the active ingredient?
- Ethambutol hydrochloride.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ethambutol Hydrochloride?
- 12 other product NDCs are listed under this name. See all Ethambutol Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ethambutol Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ethambutol Hydrochloride | Ethambutol hydrochloride 400 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2966 | 70518-2966-00 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Epic Pharma, LLC | 42806-101 | 42806-0101-01 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 400 mg/1 | Tablet, Film coatedOral | Epic Pharma, LLC | 42806-102 | 42806-0102-01 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 400 mg/1 | TabletOral | American Health Packaging | 68084-280 | 68084-0280-01 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 100 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-280 | 68180-0280-01 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 400 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-281 | 68180-0281-01 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals, Inc. | 10135-796 | 10135-0796-01 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 400 mg/1 | Tablet, Film coatedOral | Marlex Pharmaceuticals, Inc. | 10135-797 | 10135-0797-01 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 100 mg/1 | Tablet, Film coatedOral | STI Pharma LLC | 54879-001 | — |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 400 mg/1 | Tablet, Film coatedOral | STI Pharma LLC | 54879-002 | — |
Other NDCs under ANDA 078939
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ethambutol Hydrochloride | Ethambutol hydrochloride 400 mg/1 | TabletOral | American Health Packaging | 68084-280 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 100 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-280 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 400 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-281 |
| Ethambutol Hydrochloride | Ethambutol hydrochloride 400 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2966 |