Prescription drug · ANDA
Meprobamate NDC 46708-019
Meprobamate 200 mg/1 · Tablet · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-019-30 | 4670800193046708001930 | 30 TABLET in 1 BOTTLE (46708-019-30)Marketed from Jul 23, 2013 | |
| 46708-019-71 | 4670800197146708001971 | 100 TABLET in 1 BOTTLE (46708-019-71)Marketed from Jul 23, 2013 | |
| 46708-019-91 | 4670800199146708001991 | 1000 TABLET in 1 BOTTLE (46708-019-91)Marketed from Jul 23, 2013 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Meprobamate
- Generic name (nonproprietary)
- meprobamate
- Active ingredients
- Meprobamate — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090122
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Identifiers
- Product ID 46708-019_8c5c7ad8-a128-4243-bd03-0e7057295b3fSPL ID 8c5c7ad8-a128-4243-bd03-0e7057295b3fSPL set ID a0891a32-105b-48bc-a246-5e179d2e7fa1RxCUI 197928, 197929UNII 9I7LNY769QUPC 0346708020309, 0346708019303
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
N446708001930followed by a unit qualifier and the quantityPackage 46708-0019-30. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS & USAGE Meprobamate tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually do not require treatment with an anxiolytic. The effectiveness of meprobamate tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
Excerpt only. Read the full label for complete information.
About NDC 46708-019
- What is NDC 46708-019?
- 46708-019 is the product NDC for Meprobamate, Meprobamate 200 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Meprobamate.
- What is the active ingredient?
- Meprobamate.
- Who is the labeler?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Meprobamate?
- 5 other product NDCs are listed under this name. See all Meprobamate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Meprobamate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Meprobamate | Meprobamate 200 mg/1 | TabletOral | Cipla USA Inc. | 69097-974 | 69097-0974-07 |
| Meprobamate | Meprobamate 400 mg/1 | TabletOral | Cipla USA Inc. | 69097-975 | 69097-0975-07 |
| Meprobamate | Meprobamate 200 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-019 | 62332-0019-3062332-0019-3162332-0019-91 |
| Meprobamate | Meprobamate 400 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-020 | 62332-0020-3062332-0020-3162332-0020-91 |
| Meprobamate | Meprobamate 400 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-020 | 46708-0020-3046708-0020-7146708-0020-91 |
Other NDCs under ANDA 090122
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 |
|---|---|---|---|---|
| Meprobamate | Meprobamate 400 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-020 |
| Meprobamate | Meprobamate 200 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-019 |
| Meprobamate | Meprobamate 400 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-020 |